42 Regulatory Compliance jobs in Ireland
QA Regulatory Compliance Specialist
PCI Pharma Services
Posted today
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
+ Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
+ Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
+ Maintenance of Approved CMO list for Clinical Supply Chain
+ Ensure on-going compliance with customer, regulatory and internal requirements.
+ Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
+ Preparation and maintenance of the clinical approved products.
+ Preparation of QP declarations for review and approval by PCI QP
+ Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
+ Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
**Knowledge / Skills & Experience**
**Essential:**
+ Bachelor's degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
+ Minimum 2 years' experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
+ Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Client Facing experience
**Desirable:**
+ Experience in auditing of external suppliers, contractors and vendors.
+ Experience with regulatory filings.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
+ Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
+ Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
+ Maintenance of Approved CMO list for Clinical Supply Chain
+ Ensure on-going compliance with customer, regulatory and internal requirements.
+ Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
+ Preparation and maintenance of the clinical approved products.
+ Preparation of QP declarations for review and approval by PCI QP
+ Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
+ Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
**Knowledge / Skills & Experience**
**Essential:**
+ Bachelor's degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
+ Minimum 2 years' experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
+ Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Client Facing experience
**Desirable:**
+ Experience in auditing of external suppliers, contractors and vendors.
+ Experience with regulatory filings.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
0
QA Regulatory Compliance Specialist
PCI Pharma Services
Posted 8 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
+ Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
+ Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
+ Maintenance of Approved CMO list for Clinical Supply Chain
+ Ensure on-going compliance with customer, regulatory and internal requirements.
+ Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
+ Preparation and maintenance of the clinical approved products.
+ Preparation of QP declarations for review and approval by PCI QP
+ Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
+ Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
**Knowledge / Skills & Experience**
**Essential:**
+ Bachelor's degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
+ Minimum 2 years' experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
+ Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Client Facing experience
**Desirable:**
+ Experience in auditing of external suppliers, contractors and vendors.
+ Experience with regulatory filings.
**#LI-JP1**
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
+ Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
+ Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
+ Maintenance of Approved CMO list for Clinical Supply Chain
+ Ensure on-going compliance with customer, regulatory and internal requirements.
+ Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
+ Preparation and maintenance of the clinical approved products.
+ Preparation of QP declarations for review and approval by PCI QP
+ Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
+ Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
**Knowledge / Skills & Experience**
**Essential:**
+ Bachelor's degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
+ Minimum 2 years' experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
+ Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Client Facing experience
**Desirable:**
+ Experience in auditing of external suppliers, contractors and vendors.
+ Experience with regulatory filings.
**#LI-JP1**
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
1
Principal Regulatory Compliance Specialist
Dublin, Leinster
Oracle
Posted 8 days ago
Job Viewed
Job Description
**Job Description**
Oracle Cloud Infrastructure (OCI) is seeking a highly skilled and detail-oriented Regulatory Compliance Specialist to join our dynamic team. As a key player in our global organization, you will be responsible for managing audits and assessments, and informing OCI on regulatory changes so that we maintain a high level of compliance and adhere to all relevant regulations, policies, and standards.
We are looking for a Regulatory Compliance Specialist who is looking to grow their career in Cloud. You will be responsible for the support and implementation of scalable audit programs to support Oracle Cloud Infrastructure's growth in regulated markets within the Europe, Middle East, and Africa (EMEA) region with a specific focus on Europe.
The ideal candidate will have the following skills:
· 8+ years audit program management experience with either a "Big 4" accounting firm, or a mid-level accounting firm.
· 4+ years proven experience as a Regulatory Compliance Specialist or similar role.
· Knowledge of industry and regulatory frameworks is preferable, such as ISO 27000 Series, SOC 1, SOC2, ENS, ACN, Cyber Essentials+, EU CoC, TISAX, etc.
· Strong analytical and problem-solving skills.
· Excellent communication and interpersonal abilities.
· Ability to work collaboratively with cross-functional teams.
· Possess ability to explain complex auditing topics to audiences with no auditing experience.
· Ability to prioritize, manage, and deliver on multiple projects simultaneously and partner with management in support of key initiatives and projects.
· Strong bias toward action, flexible, resourceful, and able to operate effectively within a dynamic, fast-paced environment.
· Superior communication skills (interpersonal, verbal, presentation written, email, tickets, etc.)
Preferred Qualifications:
· JIRA and Confluence experience strongly preferred.
· Professional certification in regulatory compliance (i.e. PMP, PgMP, CISA, CISM, CISSP, CIPP)
#LI-DNI
**Responsibilities**
Responsibilities:
Manage Audits and Assessments:
· Plan, manage, and conduct regular compliance audits with third party auditors.
· Communicate OCI processes and policy to third party auditors effectively.
· Report findings and recommend corrective actions as needed across different stakeholder groups.
· Foster a culture of compliance awareness through regular communication and educational initiatives.
· Effectively communicate in remote working environment over video, phone, email and other tools.
Stay Informed on Regulatory Changes:
· Monitor and stay up-to-date on changes to local, national, and international regulations affecting cloud service providers in EMEA, specifically within Europe.
· Analyze the impact of regulatory changes and provide recommendations to the management team.
· Conduct regular reviews and updates of existing policies to ensure ongoing relevance.
Regulatory Reporting:
· Prepare and submit timely and accurate regulatory reports to relevant authorities in accordance with applicable regulations.
· Work closely with internal teams to gather necessary data and information for reporting purposes.
· Provide clear expectations and direction to security and engineering teams within OCI on audit requirements.
Career Level - IC4
**About Us**
As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling +1 in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
Oracle Cloud Infrastructure (OCI) is seeking a highly skilled and detail-oriented Regulatory Compliance Specialist to join our dynamic team. As a key player in our global organization, you will be responsible for managing audits and assessments, and informing OCI on regulatory changes so that we maintain a high level of compliance and adhere to all relevant regulations, policies, and standards.
We are looking for a Regulatory Compliance Specialist who is looking to grow their career in Cloud. You will be responsible for the support and implementation of scalable audit programs to support Oracle Cloud Infrastructure's growth in regulated markets within the Europe, Middle East, and Africa (EMEA) region with a specific focus on Europe.
The ideal candidate will have the following skills:
· 8+ years audit program management experience with either a "Big 4" accounting firm, or a mid-level accounting firm.
· 4+ years proven experience as a Regulatory Compliance Specialist or similar role.
· Knowledge of industry and regulatory frameworks is preferable, such as ISO 27000 Series, SOC 1, SOC2, ENS, ACN, Cyber Essentials+, EU CoC, TISAX, etc.
· Strong analytical and problem-solving skills.
· Excellent communication and interpersonal abilities.
· Ability to work collaboratively with cross-functional teams.
· Possess ability to explain complex auditing topics to audiences with no auditing experience.
· Ability to prioritize, manage, and deliver on multiple projects simultaneously and partner with management in support of key initiatives and projects.
· Strong bias toward action, flexible, resourceful, and able to operate effectively within a dynamic, fast-paced environment.
· Superior communication skills (interpersonal, verbal, presentation written, email, tickets, etc.)
Preferred Qualifications:
· JIRA and Confluence experience strongly preferred.
· Professional certification in regulatory compliance (i.e. PMP, PgMP, CISA, CISM, CISSP, CIPP)
#LI-DNI
**Responsibilities**
Responsibilities:
Manage Audits and Assessments:
· Plan, manage, and conduct regular compliance audits with third party auditors.
· Communicate OCI processes and policy to third party auditors effectively.
· Report findings and recommend corrective actions as needed across different stakeholder groups.
· Foster a culture of compliance awareness through regular communication and educational initiatives.
· Effectively communicate in remote working environment over video, phone, email and other tools.
Stay Informed on Regulatory Changes:
· Monitor and stay up-to-date on changes to local, national, and international regulations affecting cloud service providers in EMEA, specifically within Europe.
· Analyze the impact of regulatory changes and provide recommendations to the management team.
· Conduct regular reviews and updates of existing policies to ensure ongoing relevance.
Regulatory Reporting:
· Prepare and submit timely and accurate regulatory reports to relevant authorities in accordance with applicable regulations.
· Work closely with internal teams to gather necessary data and information for reporting purposes.
· Provide clear expectations and direction to security and engineering teams within OCI on audit requirements.
Career Level - IC4
**About Us**
As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling +1 in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
This advertiser has chosen not to accept applicants from your region.
2
Regulatory Compliance
Dublin, Leinster
Arcadis DPS
Posted 7 days ago
Job Viewed
Job Description
Regulatory Compliance Subject Matter Expert (SME) Arcadis is the worlds leading company in sustainable design, engineering, and consultancy for natural and built assets. With over 36,000 professionals in 70+ countries, we are united in improving quality of life and solving the worlds most complex challenges. The location is open to EU with travel. About the Role: Arcadis DPS Group specializes in Project Management, Multi-Discipline Design, and Construction Management for Pharmaceutical and Life Science Buildings. A self-motivated and results orientated person with a proven track record working directly with life science industry clients in a cGMP environment. Be part of something impactful join us! This person will fulfil the following key functions: Key Responsibilities: Ensure cGMP Compliance: Collaborate with internal project teams to ensure robust cGMP-compliant facility designs for pharmaceutical, biopharmaceutical, and Advanced Therapy Medicinal Product (ATMP) facilities. Regulatory Support: Provide expert guidance to Arcadis clients during live projects, ensuring regulatory compliance across all aspects of facility operation, including equipment, processes, and personnel. Client Engagement & Presentations: Support Arcadiss Business Development and proposal teams by delivering capability presentations to clients, displaying expertise and value propositions. Client Relationship Development: Build and manage a client base in the life sciences industry, leveraging expertise to secure specific work assignments such as: Investigating contamination issues in processes and facilities. Supporting operational readiness, including engagement with regulatory authorities. Providing expert guidance during regulatory audits, including EU and FDA inspections. Architecting quality management frameworks and systems tailored to client needs. Developing contamination control strategies aligned with regulatory guidelines and industry best practices. Experience & Skills Required: Extensive Industry Experience: Minimum of 15 years of experience within the life sciences industry, with a focus on regulatory, QA, or related roles. Specialized Consultancy Expertise: Significant career experience working directly for life sciences companies or specialist consultancies with a focus on regulatory compliance and quality assurance. Regulatory Auditor Interaction: Proven experience interacting with EU, FDA, or other regulatory auditors is highly desirable. Business Development Acumen: Demonstrated ability to drive business development efforts and cultivate new client relationships in the life sciences industry is advantageous. Regulatory Knowledge: Comprehensive understanding of applicable regulatory standards, including Eudralex, FDA guidelines, and Annex 1, paired with awareness of emerging regulatory trends and viewpoints. Educational Background: A bachelors degree in a relevant Science or Engineering discipline is required; advanced degrees or certifications in regulatory or compliance fields are a plus. Why Arcadis? At Arcadis, we empower everyone to be their best because your contribution matters. We take a skills-based approach, allowing you to shape your career and maximize your impact. By joining us, youll do meaningful work, delivering sustainable solutions for a better planet and leaving a lasting legacy. Our Commitment to Equality, Diversity, and Inclusion Were dedicated to creating a workplace where everyone can thrive. Through six ED&I workstreamsAge, Disability, Faith, Gender, LGBT+, and Racewe foster innovation by bringing together diverse perspectives. Together, we improve quality of life while building a more inclusive future. Join Arcadis. Create a Legacy.
This advertiser has chosen not to accept applicants from your region.
3
Designated Person for Regulatory Compliance - Ireland
Dublin, Leinster
BlackRock
Posted 8 days ago
Job Viewed
Job Description
**About this role**
**Role Description:**
We are currently recruiting a Designated Person for Regulatory Compliance to join BlackRock's Legal & Compliance team in Dublin, Ireland, which currently comprises 14 professionals. This role is responsible for monitoring and overseeing compliance with regulatory obligations for BlackRock's Irish UCITS Management Company and AIFM, which manages over 550 funds across multiple asset classes and investment styles, with an AUM exceeding $1 trillion.
This position will complement an existing team of over 100 compliance specialists based across the EMEA region who support the various businesses in discharging BlackRock's regulatory obligations and assist the businesses in managing regulatory risk.
The ideal candidate will be an ambitious, driven compliance professional who thrives in a fast-paced, complex environment. They will work closely with other members of the Senior Management team in Ireland and compliance teams across BlackRock's global locations. The role also involves attending and presenting management information ("MI") to relevant Board and sub-committee meetings.
We are looking for someone who can build and maintain strong partnerships, demonstrates excellent technical and regulatory knowledge, and has a proven ability to foster positive relationships. The strength of character to offer healthy challenge will be key, as will be the ability to engage successfully with business partners at all levels.
**This role is a Pre-Approved Control Function (PCF - 39F) within the scope of the Individual Accountability Framework.**
**Key Regulatory Obligations**
The successful candidate will be subject to the Common Conduct Standards and the Additional Conduct Standards set out in in Section 53E of the Central Bank Reform Act 2010), and the Fitness and Probity Standards of the Central Bank of Ireland.
As long as they remain a Pre-Approved Control Function it is their responsibility to continue to meet the required standards of fitness and probity for their role.
The ideal candidate is a highly motivated self-starter, demonstrates good judgment, has a strong team ethic, combined with high energy, intellectual curiosity, resilience and diplomacy.
**Key Responsibilities:**
*Partner and work closely with the Head of Compliance (PCF-12) in ensuring BlackRock meets its relevant regulatory obligations (e.g. UCITS, AIFMD, Fund Management Company Guidance (CP86), SFDR, Outsourcing Guidelines, Operational Resilience Guidelines, etc.).
*Work closely with other Designated Persons to share insights and maintain a clear, cross-functional view of the business and its risks.
*Develop and maintain relationships with the Regulator and provide assistance with all regulatory inspections and queries, outlining the Company's positions where appropriate and ensuring that any follow-up actions are closed out.
*Analyse regulatory and legislative developments and assess their applicability and impact to BlackRock's Fund Management Company in Ireland. Contribute and advise on the design of compliance controls, policies and procedures to enable BlackRock to align with all relevant existing and upcoming regulations, law, and applicable codes.
*Act as a point of escalation on product compliance issues, breaches and complaints related to funds under management.
*Provide advice on regulations and on the application of BlackRock's compliance policies in relation to existing and new business initiatives, issue identification and breach resolution.
*Provide reporting to senior management and the Board and relevant sub-committees on regulatory compliance matters.
*Consistently review the compliance policies and procedures to ensure they comply with relevant regulations.
*Support the further development and oversight of the Compliance Monitoring Programme.
*Oversee the completion of regulatory filings, ensuring accurate and timely reporting.
*Represent or lead for Compliance on projects, including regulatory developments and key business initiatives.
*Design and deliver effective regulatory training and guidance to the business.
*Establish strong partnerships with compliance colleagues in other EMEA locations and ensure the consistent application of controls, where possible.
*As a senior member of the team, develop less experienced team members and support colleagues with knowledge sharing and cross-training.
*Further cement the relationship between the compliance team and business partners and promote an outstanding compliance culture.
*Look for opportunities to enhance the control environment, including through the use of technology.
**Knowledge / Experience:**
*Ideally at least 15 years relevant experience within the asset management industry and previous experience as a Designated Person for Regulatory Compliance (PCF-39F) and/or Head of Compliance (PCF-12). Also, demonstrable expertise in regulation relevant to the funds industry (e.g. UCITS, AIFMD, Fund Management Company Guidance (CP86), Outsourcing Guidelines (CP138), Guidance on Operational Resilience (CP140), etc.).
*Experience in handling regulatory relationships and examinations is preferred.
*Broader advisory experience across asset classes and covering multiple jurisdictions would be an advantage.
*Consistent record of influencing business partners at all levels, including boards, delivering timely and quality regulatory advice.
*Familiarity with dealing with a multi-jurisdictional regulatory environment would be beneficial.
*Technical ability and mentality to challenge the status-quo and deliver solutions with the judgment to use this in appropriate circumstances.
*Strong written and verbal communication skills.
*Consistent ability to demonstrate high standards of accuracy and strong attention to detail.
*Excellent organisational skills with ability to prioritize workloads and progress multiple tasks.
*Ability to collaborate effectively both within the team and across functions and to work independently.
*Strong interpersonal skills with an ability to articulate complex regulatory matters and well-developed relationship management skills.
*Capable of grasping new concepts quickly and independently.
BlackRocks hybrid work model is designed to enable a culture of collaboration and apprenticeship that enriches the experience of our employees, while supporting flexibility for all. Employees are currently required to work at least 4 days in the office per week, with the flexibility to work from home 1 day a week. Some business groups may require more time in the office due to their roles and responsibilities. We remain focused on increasing the impactful moments that arise when we work together in person - aligned with our commitment to performance and innovation. As a new joiner, you can count on this hybrid model to accelerate your learning and onboarding experience here at BlackRock.
**About BlackRock**
At BlackRock, we are all connected by one mission: to help more and more people experience financial well-being. Our clients, and the people they serve, are saving for retirement, paying for their children's educations, buying homes and starting businesses. Their investments also help to strengthen the global economy: support businesses small and large; finance infrastructure projects that connect and power cities; and facilitate innovations that drive progress.
This mission would not be possible without our smartest investment - the one we make in our employees. It's why we're dedicated to creating an environment where our colleagues feel welcomed, valued and supported with networks, benefits and development opportunities to help them thrive.
For additional information on BlackRock, please visit @blackrock ( | Twitter: @blackrock ( | LinkedIn: is proud to be an Equal Opportunity Employer. We evaluate qualified applicants without regard to age, disability, race, religion, sex, sexual orientation and other protected characteristics at law.
**Our benefits**
To help you stay energized, engaged and inspired, we offer a wide range of employee benefits including: retirement investment and tools designed to help you in building a sound financial future; access to education reimbursement; comprehensive resources to support your physical health and emotional well-being; family support programs; and Flexible Time Off (FTO) so you can relax, recharge and be there for the people you care about.
**Our hybrid work model**
BlackRock's hybrid work model is designed to enable a culture of collaboration and apprenticeship that enriches the experience of our employees, while supporting flexibility for all. Employees are currently required to work at least 4 days in the office per week, with the flexibility to work from home 1 day a week. Some business groups may require more time in the office due to their roles and responsibilities. We remain focused on increasing the impactful moments that arise when we work together in person - aligned with our commitment to performance and innovation. As a new joiner, you can count on this hybrid model to accelerate your learning and onboarding experience here at BlackRock.
**About BlackRock**
At BlackRock, we are all connected by one mission: to help more and more people experience financial well-being. Our clients, and the people they serve, are saving for retirement, paying for their children's educations, buying homes and starting businesses. Their investments also help to strengthen the global economy: support businesses small and large; finance infrastructure projects that connect and power cities; and facilitate innovations that drive progress.
This mission would not be possible without our smartest investment - the one we make in our employees. It's why we're dedicated to creating an environment where our colleagues feel welcomed, valued and supported with networks, benefits and development opportunities to help them thrive.
For additional information on BlackRock, please visit @blackrock ( | Twitter: @blackrock ( | LinkedIn: is proud to be an Equal Opportunity Employer. We evaluate qualified applicants without regard to age, disability, race, religion, sex, sexual orientation and other protected characteristics at law.
**Role Description:**
We are currently recruiting a Designated Person for Regulatory Compliance to join BlackRock's Legal & Compliance team in Dublin, Ireland, which currently comprises 14 professionals. This role is responsible for monitoring and overseeing compliance with regulatory obligations for BlackRock's Irish UCITS Management Company and AIFM, which manages over 550 funds across multiple asset classes and investment styles, with an AUM exceeding $1 trillion.
This position will complement an existing team of over 100 compliance specialists based across the EMEA region who support the various businesses in discharging BlackRock's regulatory obligations and assist the businesses in managing regulatory risk.
The ideal candidate will be an ambitious, driven compliance professional who thrives in a fast-paced, complex environment. They will work closely with other members of the Senior Management team in Ireland and compliance teams across BlackRock's global locations. The role also involves attending and presenting management information ("MI") to relevant Board and sub-committee meetings.
We are looking for someone who can build and maintain strong partnerships, demonstrates excellent technical and regulatory knowledge, and has a proven ability to foster positive relationships. The strength of character to offer healthy challenge will be key, as will be the ability to engage successfully with business partners at all levels.
**This role is a Pre-Approved Control Function (PCF - 39F) within the scope of the Individual Accountability Framework.**
**Key Regulatory Obligations**
The successful candidate will be subject to the Common Conduct Standards and the Additional Conduct Standards set out in in Section 53E of the Central Bank Reform Act 2010), and the Fitness and Probity Standards of the Central Bank of Ireland.
As long as they remain a Pre-Approved Control Function it is their responsibility to continue to meet the required standards of fitness and probity for their role.
The ideal candidate is a highly motivated self-starter, demonstrates good judgment, has a strong team ethic, combined with high energy, intellectual curiosity, resilience and diplomacy.
**Key Responsibilities:**
*Partner and work closely with the Head of Compliance (PCF-12) in ensuring BlackRock meets its relevant regulatory obligations (e.g. UCITS, AIFMD, Fund Management Company Guidance (CP86), SFDR, Outsourcing Guidelines, Operational Resilience Guidelines, etc.).
*Work closely with other Designated Persons to share insights and maintain a clear, cross-functional view of the business and its risks.
*Develop and maintain relationships with the Regulator and provide assistance with all regulatory inspections and queries, outlining the Company's positions where appropriate and ensuring that any follow-up actions are closed out.
*Analyse regulatory and legislative developments and assess their applicability and impact to BlackRock's Fund Management Company in Ireland. Contribute and advise on the design of compliance controls, policies and procedures to enable BlackRock to align with all relevant existing and upcoming regulations, law, and applicable codes.
*Act as a point of escalation on product compliance issues, breaches and complaints related to funds under management.
*Provide advice on regulations and on the application of BlackRock's compliance policies in relation to existing and new business initiatives, issue identification and breach resolution.
*Provide reporting to senior management and the Board and relevant sub-committees on regulatory compliance matters.
*Consistently review the compliance policies and procedures to ensure they comply with relevant regulations.
*Support the further development and oversight of the Compliance Monitoring Programme.
*Oversee the completion of regulatory filings, ensuring accurate and timely reporting.
*Represent or lead for Compliance on projects, including regulatory developments and key business initiatives.
*Design and deliver effective regulatory training and guidance to the business.
*Establish strong partnerships with compliance colleagues in other EMEA locations and ensure the consistent application of controls, where possible.
*As a senior member of the team, develop less experienced team members and support colleagues with knowledge sharing and cross-training.
*Further cement the relationship between the compliance team and business partners and promote an outstanding compliance culture.
*Look for opportunities to enhance the control environment, including through the use of technology.
**Knowledge / Experience:**
*Ideally at least 15 years relevant experience within the asset management industry and previous experience as a Designated Person for Regulatory Compliance (PCF-39F) and/or Head of Compliance (PCF-12). Also, demonstrable expertise in regulation relevant to the funds industry (e.g. UCITS, AIFMD, Fund Management Company Guidance (CP86), Outsourcing Guidelines (CP138), Guidance on Operational Resilience (CP140), etc.).
*Experience in handling regulatory relationships and examinations is preferred.
*Broader advisory experience across asset classes and covering multiple jurisdictions would be an advantage.
*Consistent record of influencing business partners at all levels, including boards, delivering timely and quality regulatory advice.
*Familiarity with dealing with a multi-jurisdictional regulatory environment would be beneficial.
*Technical ability and mentality to challenge the status-quo and deliver solutions with the judgment to use this in appropriate circumstances.
*Strong written and verbal communication skills.
*Consistent ability to demonstrate high standards of accuracy and strong attention to detail.
*Excellent organisational skills with ability to prioritize workloads and progress multiple tasks.
*Ability to collaborate effectively both within the team and across functions and to work independently.
*Strong interpersonal skills with an ability to articulate complex regulatory matters and well-developed relationship management skills.
*Capable of grasping new concepts quickly and independently.
BlackRocks hybrid work model is designed to enable a culture of collaboration and apprenticeship that enriches the experience of our employees, while supporting flexibility for all. Employees are currently required to work at least 4 days in the office per week, with the flexibility to work from home 1 day a week. Some business groups may require more time in the office due to their roles and responsibilities. We remain focused on increasing the impactful moments that arise when we work together in person - aligned with our commitment to performance and innovation. As a new joiner, you can count on this hybrid model to accelerate your learning and onboarding experience here at BlackRock.
**About BlackRock**
At BlackRock, we are all connected by one mission: to help more and more people experience financial well-being. Our clients, and the people they serve, are saving for retirement, paying for their children's educations, buying homes and starting businesses. Their investments also help to strengthen the global economy: support businesses small and large; finance infrastructure projects that connect and power cities; and facilitate innovations that drive progress.
This mission would not be possible without our smartest investment - the one we make in our employees. It's why we're dedicated to creating an environment where our colleagues feel welcomed, valued and supported with networks, benefits and development opportunities to help them thrive.
For additional information on BlackRock, please visit @blackrock ( | Twitter: @blackrock ( | LinkedIn: is proud to be an Equal Opportunity Employer. We evaluate qualified applicants without regard to age, disability, race, religion, sex, sexual orientation and other protected characteristics at law.
**Our benefits**
To help you stay energized, engaged and inspired, we offer a wide range of employee benefits including: retirement investment and tools designed to help you in building a sound financial future; access to education reimbursement; comprehensive resources to support your physical health and emotional well-being; family support programs; and Flexible Time Off (FTO) so you can relax, recharge and be there for the people you care about.
**Our hybrid work model**
BlackRock's hybrid work model is designed to enable a culture of collaboration and apprenticeship that enriches the experience of our employees, while supporting flexibility for all. Employees are currently required to work at least 4 days in the office per week, with the flexibility to work from home 1 day a week. Some business groups may require more time in the office due to their roles and responsibilities. We remain focused on increasing the impactful moments that arise when we work together in person - aligned with our commitment to performance and innovation. As a new joiner, you can count on this hybrid model to accelerate your learning and onboarding experience here at BlackRock.
**About BlackRock**
At BlackRock, we are all connected by one mission: to help more and more people experience financial well-being. Our clients, and the people they serve, are saving for retirement, paying for their children's educations, buying homes and starting businesses. Their investments also help to strengthen the global economy: support businesses small and large; finance infrastructure projects that connect and power cities; and facilitate innovations that drive progress.
This mission would not be possible without our smartest investment - the one we make in our employees. It's why we're dedicated to creating an environment where our colleagues feel welcomed, valued and supported with networks, benefits and development opportunities to help them thrive.
For additional information on BlackRock, please visit @blackrock ( | Twitter: @blackrock ( | LinkedIn: is proud to be an Equal Opportunity Employer. We evaluate qualified applicants without regard to age, disability, race, religion, sex, sexual orientation and other protected characteristics at law.
This advertiser has chosen not to accept applicants from your region.
4
Head of Quality, Risk & Regulatory Compliance
Dublin, Leinster
Brightwater
Posted 7 days ago
Job Viewed
Job Description
Job Title Head of Quality, Risk & Regulatory Compliance Brightwater Executive is delighted to be retained exclusively by our client, St John of God University Hospital, in their search for a Head of Quality, Risk & Regulatory Compliance. About the Company St John of God Hospital CLG comprises of St John of God University Hospital, Saint Josephs Shankill and Mental Health First Aid Ireland St John of God University Hospital is an independent acute psychiatric teaching hospital with 180 inpatient beds and 370 staff. It offers outpatient services and specializes in Addictions, Psychosis, Eating Disorders, Psychiatry of Later Life, and Adolescent care. The hospital is affiliated with major Irish universities and medical colleges for healthcare training and education. Saint Josephs Shankill is Irelands largest residential facility solely for dementia care, offering residential, day, and respite services to 60 people. It employs 102 staff and is supported by 200 volunteers, leading in care through innovation, education, and community engagement. Mental Health First Aid Ireland is the only licensed provider of mental health first aid training in Ireland, having trained over 27,000 people. It helps improve mental health literacy, reduce stigma, and enhance support-giving behaviours. About the Position Reporting directly to the Chief Executive, the Head of Quality, Compliance & Risk provides senior leadership in quality improvement, patient safety, regulatory compliance, and risk management across St John of God University Hospital and St Josephs Centre Shankill. The role supports the clinical governance framework and ensures services are safe, effective, compassionate, and data-driven. The post holder drives continuous improvement, minimises risk, and upholds the ethos and values of the St John of God Hospitaller Services Group, ensuring all quality and regulatory standards are met and maintained. Key Responsibilities Strategic Leadership: Promote a vision that positions St John of God University Hospital as a national and international leader in clinical governance, quality improvement, regulatory compliance, and risk management. Planning & Implementation: Lead the development and delivery of strategic and annual operational plans for quality, compliance, risk management, and clinical governance across all services. Regulatory Oversight: Ensure adherence to all regulatory standards; lead preparation for inspections (e.g. MHC, HIQA, HPRA) and manage post-inspection action plans within agreed timeframes. Monitoring & Reporting: Oversee audit schedules, review findings, and provide performance reports and trend analyses to senior management and the Board. Policy & Quality Frameworks: Maintain and enhance policies, procedures, and document control systems in line with strategic objectives and best practice standards. Education & Culture: Foster a culture of continuous improvement; lead training and education in quality and compliance for staff, clinicians, and Board members. Collaboration & Management: Support departmental leaders in achieving quality goals and line-manage the quality, risk, and compliance function while collaborating with Infection Control and Health & Safety teams. Experience/Requirements A third-level degree in a healthcare related discipline with a postgraduate qualification required. Proven track record of strategic leadership experience in senior quality and regulatory compliance roles within complex health services. Demonstrated success in leading quality and compliance teams, managing quality programmes, and delivering measurable improvements. Strong understanding of the healthcare sector, with the ability to benchmark services against national and international peers. In-depth knowledge of GDPR, Data Protection and Information Governance, with the capability to lead and manage change from identification through to evaluation. A team player with the ability to motivate, lead, and build strong collaborative relationships to achieve quality and compliance goals. Excellent written and verbal communication skills, with the ability to influence and negotiate effectively at all levels. Contact For more information and/ or a confidential discussion on this Head of Quality, Risk & Regulatory Compliance opportunity, please send your CV to Yvonne McNulty at Brightwater Executive Skills: Leadership Compliance Quality Patient Safety
This advertiser has chosen not to accept applicants from your region.
5
Compliance Specialist
Cootehill, Ulster
Abbott
Posted 8 days ago
Job Viewed
Job Description
**About Abbott**
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 6000 people across tensites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
**Abbott Ireland Vascular Division Clonmel**
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education.
Our broad line of vascular devices-which includes vessel closure, endovascular and coronary technologies-are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.
**PURPOSE OF THE JOB**
+ This role will provide leadership in the areas of Plant Compliance, Strategic Compliance initiatives, cGMP and Food Safety within Manufacturing. This will include a responsibility in providing direction for continuous improvement.
**MAJOR RESPONSIBILITIES**
+ Follow all Environmental, Health and Safety Rules and Regulations in the plant.
+ Report any current or potential hazards to your manager immediately.
+ Wear the correct Personal Protective Equipment (P.P.E) at all times. Consult the appropriate SOP where required.
+ Play an active role in the Food Safety Management Team with responsibility for the HACCP Programme
+ Responsibility for reviewing all SOP's for any job task he/she may carry out and ensure he/she fully understands and adheres to the SOP.
+ Lead strategic quality initiatives in the areas Compliance and other specific areas.
+ Key role in implementation and management of the audit readiness in Manufacturing
+ Develop, identify, analyse, manage and communicate compliance matrices
+ Ensuring Compliance to all Regulations/Legislation applicable to Manufacturing.
+ Develop and deliver training with regard to compliance based on business needs.
+ Play a key role in the Plant Compliance to ensure all new equipment/processes and any new infrastructure meets cGMP standards and regulatory compliance.
+ Manage the Manufacturing Department Janitorial requirements and staff.
+ Ensure compliance to all Corporate and Division Policies in the area of responsibility.
+ Benchmark activities to ensure current cGMP is consistent with Infant Formulae Nutritional Industry.
+ Responsible for auditing of the Manufacturing Department
+ Participate as a lead auditor within the plant in internal audit schedule, plant walk-downs and external audits.
+ Manage and co-ordinate bi-weekly compliance walk-down programme activities.
+ Play a key role in ensuring the plant is audit ready for CRQS, Division and regulatory audits.
+ Responsible for the oversight of the plant sanitation programme and liaising with third party cleaning contractor who have responsibility for cleaning, sanitization, Environmental Monitoring Programme and pest control.
+ Accountable for compliance to all local and US federal regulations, all applicable food safety policies and procedures.
+ Responsible for reporting of the site sanitation programme performance at monthly management review and through management activities.
+ This Job function will change where update procedures to GMP, EHS, Technical / New Equipment, Quality Procedures & SOP's are made.
+ This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible were this need arises.
**EDUCATION & COMPETENCIES**
+ A Diploma/Degree in Food Science/Chemistry/Quality or a Third level qualification in a related discipline.
+ Very good understanding of the manufacturing process.
+ Strong knowledge and experience in auditing, analytical techniques and methods used.
+ Excellent interpersonal skills and management skills.
+ Ability to: communicate with all levels of the organization, communicate effectively with cross-functional team.
+ This function will have responsibility to ensure that Compliance is managed effectively and will provide leadership in the areas of Manufacturing Compliance, Strategic Compliance initiatives, cGMP and Food Safety.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 6000 people across tensites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
**Abbott Ireland Vascular Division Clonmel**
Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education.
Our broad line of vascular devices-which includes vessel closure, endovascular and coronary technologies-are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.
**PURPOSE OF THE JOB**
+ This role will provide leadership in the areas of Plant Compliance, Strategic Compliance initiatives, cGMP and Food Safety within Manufacturing. This will include a responsibility in providing direction for continuous improvement.
**MAJOR RESPONSIBILITIES**
+ Follow all Environmental, Health and Safety Rules and Regulations in the plant.
+ Report any current or potential hazards to your manager immediately.
+ Wear the correct Personal Protective Equipment (P.P.E) at all times. Consult the appropriate SOP where required.
+ Play an active role in the Food Safety Management Team with responsibility for the HACCP Programme
+ Responsibility for reviewing all SOP's for any job task he/she may carry out and ensure he/she fully understands and adheres to the SOP.
+ Lead strategic quality initiatives in the areas Compliance and other specific areas.
+ Key role in implementation and management of the audit readiness in Manufacturing
+ Develop, identify, analyse, manage and communicate compliance matrices
+ Ensuring Compliance to all Regulations/Legislation applicable to Manufacturing.
+ Develop and deliver training with regard to compliance based on business needs.
+ Play a key role in the Plant Compliance to ensure all new equipment/processes and any new infrastructure meets cGMP standards and regulatory compliance.
+ Manage the Manufacturing Department Janitorial requirements and staff.
+ Ensure compliance to all Corporate and Division Policies in the area of responsibility.
+ Benchmark activities to ensure current cGMP is consistent with Infant Formulae Nutritional Industry.
+ Responsible for auditing of the Manufacturing Department
+ Participate as a lead auditor within the plant in internal audit schedule, plant walk-downs and external audits.
+ Manage and co-ordinate bi-weekly compliance walk-down programme activities.
+ Play a key role in ensuring the plant is audit ready for CRQS, Division and regulatory audits.
+ Responsible for the oversight of the plant sanitation programme and liaising with third party cleaning contractor who have responsibility for cleaning, sanitization, Environmental Monitoring Programme and pest control.
+ Accountable for compliance to all local and US federal regulations, all applicable food safety policies and procedures.
+ Responsible for reporting of the site sanitation programme performance at monthly management review and through management activities.
+ This Job function will change where update procedures to GMP, EHS, Technical / New Equipment, Quality Procedures & SOP's are made.
+ This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible were this need arises.
**EDUCATION & COMPETENCIES**
+ A Diploma/Degree in Food Science/Chemistry/Quality or a Third level qualification in a related discipline.
+ Very good understanding of the manufacturing process.
+ Strong knowledge and experience in auditing, analytical techniques and methods used.
+ Excellent interpersonal skills and management skills.
+ Ability to: communicate with all levels of the organization, communicate effectively with cross-functional team.
+ This function will have responsibility to ensure that Compliance is managed effectively and will provide leadership in the areas of Manufacturing Compliance, Strategic Compliance initiatives, cGMP and Food Safety.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
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6
Compliance Specialist
Dublin, Leinster
MetLife International
Posted 7 days ago
Job Viewed
Job Description
The Team You Will Join This role is part of the Compliance Risk Management Department, supporting compliance of MetLifes Ireland and Freedom of Service (FoS) business in European markets. The team assists the Company Chief Compliance Officer in overseeing Ireland and FOS businesses, contributing to the wider central and Company Compliance activities, initiatives and projects, reporting compliance matters internally and externally, providing advisory and support in relation to Ireland and FoS business related compliance activities in line with local laws and regulations. The Opportunity TheCompliance Specialistis responsible for supporting business development and protecting the company from sanctions, fines and reputational damage. They help ensure that MetLife Ireland and FoS business are conducted in compliance with ethical business practices, MetLife policies, EU and the Central Bank of Irelands legal and regulatory expectations. They are responsible for the implementation and embeddedness of the compliance risk management framework, and fulfilment of the compliance oversight programs including but not limited to Ireland and FOS third-party distribution network in Europe and outsourced operations. How Youll Help Us Build a Confident Future (Key Responsibilities) Support business partners in designing and executing business growth activities in line with compliance requirements arising from local legal and regulatory requirements and Company policies Embed the Compliance Risk Management Framework and support in execution of the Non-Financial Risk Assessment (NFRA) roll-out/campaigns, review and challenge 1st line input, as applicable, with the aim to identify and mitigate compliance risks across the business. Plan and perform risk-based testing and monitoring activities for Ireland and FOS business Oversee compliance issues management and ensure proper and timely intervention in the case of regulatory breaches, fraudulent activity, regulatory interaction, regulatory change, compliance reporting, etc Facilitate ad-hoc or scheduled regulatory returns, reporting or applications as required for Ireland and FOS business. Participate in Ireland and FOS related governance meetings, as required Perform other Compliance Ireland and FOS oversight activities such as products review, sales/marketing materials review and alignment with local laws, regulations and company policies, customer complaints review and proper handling and other metrics collection, analysis and reporting Partner with the Ireland and FOS business functions and relevant stakeholders to identify compliance risks and advise measures to address any identified control weaknesses Ensure that business practices are compliant with all privacy and data protection laws Work with the relevant stakeholders to update compliance-related metrics and highlight trends, issues or breaches that guide management reporting and effective oversight and management of compliance risks Report at regular intervals to the Compliance Director and Chief Compliance Officer on all compliance related issues, timely and accurately Attend project meetings and provide Compliance input and challenge throughout the project lifecycle Responsible for maintenance of all compliance registers and logs related to Ireland FOS Participate in Employee Engagement and sustainability efforts. What You Need to Succeed (Required Qualifications) Experience of working within the Compliance/internal control-related areas for at least 3 years, preferably in insurance or financial industry risk management, legal, internal audit Knowledge of regulatory requirements for financial services businesses especially insurance business Experience with preparing and reviewing metrics and reports, a strong excel and PowerPoint knowledge are essential; ability to leverage AI solutions is a plus Ability to communicate effectively (both written and verbal) with all levels of the organization Organizational skills with ability to manage multiple priorities and work with various leaders within the business Critical thinking/good analytical skills Active participation and ability to support in transformation efforts incl. AI Proactive thinking and planning, with ability to contribute as an individual and as a team member Be empathetic with others Ability to turn challenges intoopportunities; solutions oriented University degree and appropriate professional qualifications (or working towards) Business acumen and commercial awareness Influencing and gaining commitment Flexible and adaptable style Ability to demonstrate MetLifes Success principles in the day-to-day job and operate in line with MetLifes New Frontier strategy.
This advertiser has chosen not to accept applicants from your region.
7
Integrity Compliance Specialist
Dublin, Leinster
Meta
Posted 8 days ago
Job Viewed
Job Description
**Summary:**
Meta is seeking a highly skilled Integrity Compliance Specialist to join our EU/UK Integrity Compliance Office. As a key member of our team, you will play a critical role in operationalising and scaling our compliance monitoring and oversight efforts in relation to the Digital Services Act (DSA), Terrorist Content Online Regulation (TCOR), and Online Safety Media Regulation Act (OSMRA) as well as commitments made to regulators as a result of investigations or in accordance with Codes of Conduct. In this exciting role, you will have the opportunity to work closely with cross-functional teams to design, implement, and maintain effective compliance monitoring programs that ensure Meta's products and services meet regulatory requirements. Your expertise will help us navigate the complex landscape of integrity compliance, mitigate risks, and promote a safe online environment for our users.If you are passionate about integrity compliance and have a demonstrated understanding of regulatory frameworks, we encourage you to apply for this rewarding opportunity. Join our team and contribute to shaping the future of online safety and compliance at Meta.
**Required Skills:**
Integrity Compliance Specialist Responsibilities:
1. Develop and maintain an understanding of regulatory requirements related to the Digital Services Act (DSA), Terrorist Content Online Regulation(TCOR), Online Safety Media Regulation Act (OSMRA) and various codes of conduct and new and emerging regional regulation
2. Collaborate with cross-functional teams to design, implement, and maintain an effective compliance monitoring program that meet regulatory requirements
3. Identify areas for improvement in our compliance monitoring processes
4. Design and implement compliance monitoring metrics and reporting dashboards to track compliance with regulatory requirements
5. Develop and maintain relationships with internal stakeholders to ensure effective communication and coordination on compliance matters
6. Identify and escalate potential compliance issues to Executive stakeholders, Executives, Leaders, Leadership team, decision makers and other relevant stakeholders
7. Ensure that compliance monitoring policies and procedures are up-to-date and reflect changes in regulatory requirements
8. Identify and assess risks associated with non-compliance with regulatory requirements
9. Build and maintain relationships with internal stakeholders, including product, engineering, and operations teams
10. Prepare regular reports on compliance monitoring activities and outcomes for Executive stakeholders, Executives, Leaders, Leadership team, decision makers and other stakeholders
11. Maintain accurate and complete records of compliance monitoring activities, including policies, procedures, and training materials
12. Ensure that all compliance monitoring documentation & evidence repository is up-to-date and reflects changes in regulatory requirements
**Minimum Qualifications:**
Minimum Qualifications:
13. 4+ years of experience in building, developing, maintaining and scaling frameworks in a tech or regulated environment
14. 4+ year's experience with the specific content regulation subject matter expertise
**Preferred Qualifications:**
Preferred Qualifications:
15. Demonstrated experience within a technology, regulatory, or consulting sector
16. Experience in building and developing compliance frameworks, policies and procedures
17. Demonstrated experience of scaling compliance monitoring in a regulated environment
18. Demonstrated experience interfacing with all levels of partners and stakeholders
19. Operational experience and understanding content-related regulations and regulatory landscape
20. Demonstrated experience liaising with internal audiences such as legal and auditors
21. Demonstrated experience in the preparation and delivery of updates to Boards, Executive stakeholders, Executives, Leaders, Leadership team, decision makers
**Industry:** Internet
Meta is seeking a highly skilled Integrity Compliance Specialist to join our EU/UK Integrity Compliance Office. As a key member of our team, you will play a critical role in operationalising and scaling our compliance monitoring and oversight efforts in relation to the Digital Services Act (DSA), Terrorist Content Online Regulation (TCOR), and Online Safety Media Regulation Act (OSMRA) as well as commitments made to regulators as a result of investigations or in accordance with Codes of Conduct. In this exciting role, you will have the opportunity to work closely with cross-functional teams to design, implement, and maintain effective compliance monitoring programs that ensure Meta's products and services meet regulatory requirements. Your expertise will help us navigate the complex landscape of integrity compliance, mitigate risks, and promote a safe online environment for our users.If you are passionate about integrity compliance and have a demonstrated understanding of regulatory frameworks, we encourage you to apply for this rewarding opportunity. Join our team and contribute to shaping the future of online safety and compliance at Meta.
**Required Skills:**
Integrity Compliance Specialist Responsibilities:
1. Develop and maintain an understanding of regulatory requirements related to the Digital Services Act (DSA), Terrorist Content Online Regulation(TCOR), Online Safety Media Regulation Act (OSMRA) and various codes of conduct and new and emerging regional regulation
2. Collaborate with cross-functional teams to design, implement, and maintain an effective compliance monitoring program that meet regulatory requirements
3. Identify areas for improvement in our compliance monitoring processes
4. Design and implement compliance monitoring metrics and reporting dashboards to track compliance with regulatory requirements
5. Develop and maintain relationships with internal stakeholders to ensure effective communication and coordination on compliance matters
6. Identify and escalate potential compliance issues to Executive stakeholders, Executives, Leaders, Leadership team, decision makers and other relevant stakeholders
7. Ensure that compliance monitoring policies and procedures are up-to-date and reflect changes in regulatory requirements
8. Identify and assess risks associated with non-compliance with regulatory requirements
9. Build and maintain relationships with internal stakeholders, including product, engineering, and operations teams
10. Prepare regular reports on compliance monitoring activities and outcomes for Executive stakeholders, Executives, Leaders, Leadership team, decision makers and other stakeholders
11. Maintain accurate and complete records of compliance monitoring activities, including policies, procedures, and training materials
12. Ensure that all compliance monitoring documentation & evidence repository is up-to-date and reflects changes in regulatory requirements
**Minimum Qualifications:**
Minimum Qualifications:
13. 4+ years of experience in building, developing, maintaining and scaling frameworks in a tech or regulated environment
14. 4+ year's experience with the specific content regulation subject matter expertise
**Preferred Qualifications:**
Preferred Qualifications:
15. Demonstrated experience within a technology, regulatory, or consulting sector
16. Experience in building and developing compliance frameworks, policies and procedures
17. Demonstrated experience of scaling compliance monitoring in a regulated environment
18. Demonstrated experience interfacing with all levels of partners and stakeholders
19. Operational experience and understanding content-related regulations and regulatory landscape
20. Demonstrated experience liaising with internal audiences such as legal and auditors
21. Demonstrated experience in the preparation and delivery of updates to Boards, Executive stakeholders, Executives, Leaders, Leadership team, decision makers
**Industry:** Internet
This advertiser has chosen not to accept applicants from your region.
8
Operations Compliance Specialist
Cork, Munster
Life Science Consultants (LSC)
Posted 7 days ago
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Job Description
LSC have a great contract opportunity for an Operations Compliance Specialist to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use. ABOUT THE PROJECT - KEY RESPONSIBILITIES: Manage the authoring & drafting of all types of Manufacturing Operations documentation. Specifications & associated forms in conjunction with the various departmental subject matter experts (SME) Support document updates and manage timelines for cross functional Projects. Act as a SME/Superuser on the Controlled Document System to facilitate the processing & approval of documents. Organise & Facilitate Document Round Table meetings with cross functional teams as required Mange and build Quality Veeva QMS metrics for Manufacturing Operations Coach & Train colleagues in Documentation System & GDP queries ABOUT YOU - ARE YOUR SKILLS A MATCH? Working knowledge in Regulations, GMP, GDP 2+ working within a regulated healthcare industry including a role in capacity of quality and compliance. Experience using Veeva is essential Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Sarina Abdulha at LSC on if you have any more questions about this opportunity! Skills: CAPA Compliance Deviation Handling Veeva GMP
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