40 Compliance Specialist jobs in Ireland
Compliance Specialist
Cootehill, Ulster
Abbott
Posted 9 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.
0
Compliance Specialist
Dublin, Leinster
MetLife International
Posted 8 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.
1
Integrity Compliance Specialist
Dublin, Leinster
Meta
Posted 9 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.
2
Operations Compliance Specialist
Cork, Munster
Life Science Consultants (LSC)
Posted 8 days ago
Job Viewed
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
This advertiser has chosen not to accept applicants from your region.
3
Quality Compliance Specialist
Limerick, Munster
Regeneron Ireland DAC
Posted 17 days ago
Job Viewed
Job Description
Within this role you'll be responsible for maintaining the site's compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. As a Quality Compliance Specialist, a typical day might include, but is not limited to, the following Being responsible for ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management. Administrating and oversight of site quality systems including but not limited to; Deviations CAPA Change Control Audits Customer Complaints Quality Risk Management Reviewing and approval of the following types of documents, relating to area functions: failure investigations change control documents corrective/preventative action documents standard operating procedures Maintaining electronic systems used for Change Control and Deviation Management Reviewing procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements Monitoring and trending metrics associated with site quality systems Participate in continuous improvement initiatives Participating in regulatory and customer audits Participating in quality risk assessments Collaborating with functional departments to resolve issues and maintain compliance Identifying gaps in systems and develop feasible plans for correction Training of personnel on quality system processes This role might be for you if you: Have proven experience in conducting on-site investigations and analysis (GEMBA walks) Have the ability to identify and address operational inefficiencies Have a track record of implementing process improvements based on findings from direct workplace engagement Can demonstrate respectful behaviour at all times Have basic working knowledge of Microsoft Suite (Word, Excel, Powerpoint To be considered for this positon you must hold BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of relevant work experience in pharmaceutical or related industry Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
This advertiser has chosen not to accept applicants from your region.
4
QA Regulatory Compliance Specialist
PCI Pharma Services
Posted 1 day 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.
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.
5
QA Regulatory Compliance Specialist
PCI Pharma Services
Posted 9 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.
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6
Principal Regulatory Compliance Specialist
Dublin, Leinster
Oracle
Posted 9 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.
7
Information Security Compliance Specialist
Cork, Munster
McAfee, Inc.
Posted 8 days ago
Job Viewed
Job Description
**_Role Overview:_**
We are seeking a detail-oriented and collaborative Information Security Compliance Specialist to join our team. In this role, you will be responsible for managing and maintaining McAfee's key information security compliance programs-primarily ISO/IEC 2700x and SOC 2 Type II, as well as contributing to McAfee's overall information security compliance program.
This is a position based in Ireland preferably in either Dublin or Cork. You may be required to be onsite when needed. We are only considering candidates within a commutable distance to one of the two locations and are not offering relocation assistance at this time.
**_About the Role_**
+ Responsible for maintaining McAfee's information security compliance certifications, specifically ISO2700x.
+ Responsible for facilitating internal and external information security audits, engaging internal and external stakeholders to meet audit requirements.
+ Responsible for continuous monitoring of McAfee's information security compliance, including managing any issues and collaborating with business stakeholders to drive remediation.
+ Maintaining strong working relationships with individuals and groups involved in managing information security compliance across the organizations.
+ Responsible for developing and sharing information security policies, ability to adapt information security policies based on changes to information security frameworks.
**_About You_**
+ 2-5 years experience in information security compliance function.
+ Experience with regulatory compliance, including information security management frameworks (e.g., NIST CSF, ISO2700x, PCI, SANS Top 20 Critical Security Controls, SOX, COBIT).
+ Excellent communication skills and business acumen.
+ The ability to translate technical language into business terms.
+ The ability to tell a story in your presentations, both verbal and written.
+ The ability to work in a fast-paced environment.
+ Preferably a Bachelor's Degree in Business Administration, Business Information Systems, Cybersecurity, Computer Science, or a related field, or equivalent work experience.
+ Security certifications such as CISSP, CISA, CISM, ISO 27001 Lead Implementor / Auditor or PCI ISA are preferred.
#LI-Remote
**_Company Overview_**
McAfee is a leader in personal security for consumers. Focused on protecting people, not just devices, McAfee consumer solutions adapt to users' needs in an always online world, empowering them to live securely through integrated, intuitive solutions that protects their families and communities with the right security at the right moment.
**_Company Benefits and Perks:_**
We work hard to embrace diversity and inclusion and encourage everyone at McAfee to bring their authentic selves to work every day. We offer a variety of social programs, flexible work hours and family-friendly benefits to all of our employees.
+ Bonus Program
+ Pension and Retirement Plans
+ Medical, Dental and Vision Coverage
+ Paid Time Off
+ Paid Parental Leave
+ Support for Community Involvement
We're serious about our commitment to diversity which is why McAfee prohibits discrimination based on race, color, religion, gender, national origin, age, disability, veteran status, marital status, pregnancy, gender expression or identity, sexual orientation or any other legally protected status.
We are seeking a detail-oriented and collaborative Information Security Compliance Specialist to join our team. In this role, you will be responsible for managing and maintaining McAfee's key information security compliance programs-primarily ISO/IEC 2700x and SOC 2 Type II, as well as contributing to McAfee's overall information security compliance program.
This is a position based in Ireland preferably in either Dublin or Cork. You may be required to be onsite when needed. We are only considering candidates within a commutable distance to one of the two locations and are not offering relocation assistance at this time.
**_About the Role_**
+ Responsible for maintaining McAfee's information security compliance certifications, specifically ISO2700x.
+ Responsible for facilitating internal and external information security audits, engaging internal and external stakeholders to meet audit requirements.
+ Responsible for continuous monitoring of McAfee's information security compliance, including managing any issues and collaborating with business stakeholders to drive remediation.
+ Maintaining strong working relationships with individuals and groups involved in managing information security compliance across the organizations.
+ Responsible for developing and sharing information security policies, ability to adapt information security policies based on changes to information security frameworks.
**_About You_**
+ 2-5 years experience in information security compliance function.
+ Experience with regulatory compliance, including information security management frameworks (e.g., NIST CSF, ISO2700x, PCI, SANS Top 20 Critical Security Controls, SOX, COBIT).
+ Excellent communication skills and business acumen.
+ The ability to translate technical language into business terms.
+ The ability to tell a story in your presentations, both verbal and written.
+ The ability to work in a fast-paced environment.
+ Preferably a Bachelor's Degree in Business Administration, Business Information Systems, Cybersecurity, Computer Science, or a related field, or equivalent work experience.
+ Security certifications such as CISSP, CISA, CISM, ISO 27001 Lead Implementor / Auditor or PCI ISA are preferred.
#LI-Remote
**_Company Overview_**
McAfee is a leader in personal security for consumers. Focused on protecting people, not just devices, McAfee consumer solutions adapt to users' needs in an always online world, empowering them to live securely through integrated, intuitive solutions that protects their families and communities with the right security at the right moment.
**_Company Benefits and Perks:_**
We work hard to embrace diversity and inclusion and encourage everyone at McAfee to bring their authentic selves to work every day. We offer a variety of social programs, flexible work hours and family-friendly benefits to all of our employees.
+ Bonus Program
+ Pension and Retirement Plans
+ Medical, Dental and Vision Coverage
+ Paid Time Off
+ Paid Parental Leave
+ Support for Community Involvement
We're serious about our commitment to diversity which is why McAfee prohibits discrimination based on race, color, religion, gender, national origin, age, disability, veteran status, marital status, pregnancy, gender expression or identity, sexual orientation or any other legally protected status.
This advertiser has chosen not to accept applicants from your region.
8
QA Compliance Specialist - Senior
Dublin, Leinster
Life Science Consultants (LSC)
Posted 5 days ago
Job Viewed
Job Description
LSC have a great contract opportunity for a Senior QA Specialist - Compliance to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life. If you have 2+ years industrial experience and are ready for your next challenge, this could be the perfect project for you! Key Responsibilities: * Review and approve quality agreements. * Release incoming materials for use in manufacturing operations * Support qualification of new suppliers/materials and requalification of existing. * Assess supplier change notifications for impact to qualification status. * Support material certification and direct dispense programs. * Review and approve quality agreements. * Authoring, review and approval of QA-related procedures. * Support OpEx programs and champion continuous quality improvement initiatives. * QA review, assessment and approval activities for Biologics Manufacture, as applicable, for: o Change controls o Deviations/Investigations o CAPAs o Other associated documentation Qualifications & Experience BSc in Science or related discipline with a minimum of 2 years' Supplier Quality or related experience in a Biologics or Pharmaceutical environment. A clear understanding of cGMP requirements for QA systems and compliance and/or manufacturing. Detailed knowledge of Biologics Processing would be a distinct advantage. Required to work on his/her own initiative in addition to working as part of a team. Excellent communication, presentation, time-management and organizational skills are essential. Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level. Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please understand that we are unable to provide visa sponsorship. Thank you. Apply via this advert or contact Siobhan Cummins on 0 if you have any more questions about this opportunity! Skills: Compliance Supplier Quality
This advertiser has chosen not to accept applicants from your region.
9