22 Compliance Management jobs in Ireland

Regulatory Compliance

Dublin, Leinster Arcadis DPS

Posted 8 days ago

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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.
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Head of Risk Management & Compliance - GBS

Dublin, Leinster AECOM

Posted 9 days ago

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**Company Description**
**Work with Us. Change the World.**
At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the worldâ?s most complex challenges and build legacies for future generations.
There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world.
We're one global team driven by our common purpose to deliver a better world. Join us.
**Job Description**
This role will lead the design, implementation, and evolution of a robust compliance and controls framework across GBS. This role is central to ensuring that Global Business Services operates in accordance with all relevant laws, regulations, and internal policies, including Sarbanes-Oxley (SOX). The 'Head of Risk Management & Compliance' will directly support the Global Process Owner (GPO) for Record to Analyze, partner with Service Delivery Leads (SDLs) across all functional Finance and HR towers and align closely with GBS Project Teams to embed controls into transformation and digitization initiatives.
The role will also be responsible for building and managing a high-performing compliance team across the Global Business Services (GBS) hubs.
**Risk Assessment and Mitigation.** Collaborate with GPOs and SDLs to:
+ Lead GBS-wide compliance risk assessments and control mapping.
+ Develop, maintain, and evolve SOX narratives and control documentation for GBS processes.
+ Partner with GPOs to embed controls into standard processes and with SDLs to ensure ongoing operational compliance.
+ Advise SDLs on risk mitigation actions and control execution gaps.
**Training and Communication.** Collaborate with SDLs, GPOs and HR (for onboarding) to:
+ Design and deliver training programs tailored to compliance requirements across all GBS towers.
+ Ensure consistent communication of policy updates and new control expectations across GBS teams.
+ Create compliance toolkits to support SDLs in coaching their teams.
**Auditing and Compliance Monitoring.** Collaborate with Internal/External Audit, Project Teams, SDLs to:
+ Lead the planning and execution of periodic compliance audits and self-assessments.
+ Implement a structured self-testing program across all functional towers to proactively identify and remediate control gaps before internal/external audits.
+ Train SDLs and tower teams on executing periodic self-assessments and interpreting results.
+ Track trends across self-testing outcomes and escalate systemic issues to GPOs and senior GBS leadership.
+ Monitor real-time compliance across all delivery hubs and flag emerging issues.
+ Coordinate remediation efforts with SDLs and track closure of compliance gaps.
+ Ensure new projects (automation, transitions) have built-in compliance checkpoints by working with Project Teams.
+ Partner with internal and external auditors to ensure compliance with relevant local regulatory requirements.
**Change & Project Compliance Integration.** Collaborate with Project Teams, GPOs and IT to:
+ Ensure all GBS-led projects include compliance and control design from the start.
+ Review and approve compliance frameworks for new tools and workflows.
+ Align with the GPO to ensure process design changes meet compliance requirements.
**People Leadership and Development**
+ Build and lead a globally distributed compliance team.
+ Set performance objectives aligned to GBS goals.
+ Foster a strong compliance culture through coaching, recognition, and development.
**Qualifications**
+ CPA or equivalent professional accounting qualification.
+ Minimum 10 years of experience, with at least 5 years in a global organization.
+ Deep expertise in SOX and operational compliance in shared services.
+ Strong leadership, communication, and stakeholder management skills.
+ Demonstrated success in cross-cultural, virtual team environments.
+ Flexible on location but will preferably be based in one of our GBS hub locations: Bangalore, Bucharest, or Manila.
**Additional Information**
+ Ability to obtain information and identify key issues and relationships relevant to achieving a long-term goal or vision **(Strategic Decision Making)**
+ Ability to understand various business scenarios and make sound decisions by combining relevant factors to arrive at the best outcome **(Business Acumen)**
+ Ability to drive to create experiences and opportunities that will lead to innovation. Ability to guide and influence other to navigate change. **(Leading Change)**
+ Ability to gather, integrate, validate, and analyze relevant data to develop resolutions, findings, and recommendations. **(Analytical Thinking)**
+ Ability to provide timely guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task and ability to support direct reports to achieve desired performance and output **(Coaching)**
+ Ability to maintain a high level of collaboration among multiple internal and external stakeholders to effectively arrive at solutions and develop initiatives. **(Collaboration)**
+ Ability to effectively communicate and collaborate with various internal and external customers globally. Ability to use tact and discretion in delivering critical and sensitive information to peers, stakeholders, and direct reports. **(Communication)**
+ Ability to actively identify new areas for learning and opportunities to improve processes, tools, and mindset **(Continuous improvement)**
+ Ability to maintain good customer relationship and initiate ways to improve customer experience **(Customer service)**
+ Ability to clearly define objectives and set targets for the team that are consistent with and compliant to service delivery agreements, key performance indicators, and policies. **(Planning and Organizing)**
+ Ability to identify and resolve varied and complex issues by applying best practices and technical expertise and ability to recommend solutions for recurring and unique scenarios. **(Problem Solving)**
+ Ability to monitor and measure progress and effectively drive individual and team results that supports the overall goal of the team. **(Results Oriented)**
**About AECOM**
AECOM is proud to offer comprehensive benefits to meet the diverse needs of our employees. Depending on your employment status, AECOM benefits may include medical, dental, vision, life, AD&D, disability benefits, paid time off, leaves of absences, voluntary benefits, perks, flexible work options, well-being resources, employee assistance program, business travel insurance, service recognition awards, retirement savings plan, and employee stock purchase plan.
AECOM is the global infrastructure leader, committed to delivering a better world. As a trusted professional services firm powered by deep technical abilities, we solve our clients' complex challenges in water, environment, energy, transportation and buildings. Our teams partner with public- and private-sector clients to create innovative, sustainable and resilient solutions throughout the project lifecycle - from advisory, planning, design and engineering to program and construction management. AECOM is a Fortune 500 firm that had revenue of $16.1 billion in fiscal year 2024. Learn more at aecom.com.
**What makes AECOM a great place to work**
You will be part of a global team that champions your growth and career ambitions. Work on groundbreaking projects - both in your local community and on a global scale - that are transforming our industry and shaping the future. With cutting-edge technology and a network of experts, you'll have the resources to make a real impact. Our award-winning training and development programs are designed to expand your technical expertise and leadership skills, helping you build the career you've always envisioned. Here, you'll find a welcoming workplace built on respect, collaboration and community - where you have the freedom to grow in a world of opportunity.
As an Equal Opportunity Employer, we believe in your potential and are here to help you achieve it. All your information will be kept confidential according to EEO guidelines.
**ReqID:** J10131547
**Business Line:** Geography OH
**Business Group:** DCS
**Strategic Business Unit:** GBS
**Career Area:** Finance
**Work Location Model:** Hybrid
**Legal Entity:** AECOM Global Business Services - Philippines ROHQ
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QA Regulatory Compliance Specialist

PCI Pharma Services

Posted 1 day ago

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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
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QA Regulatory Compliance Specialist

PCI Pharma Services

Posted 9 days ago

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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
This advertiser has chosen not to accept applicants from your region.

Principal Regulatory Compliance Specialist

Dublin, Leinster Oracle

Posted 9 days ago

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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.
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Head of Quality, Risk & Regulatory Compliance

Dublin, Leinster Brightwater

Posted 8 days ago

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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
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Risk Management Consultant

Dublin, Leinster Abrivia

Posted 8 days ago

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Job Title: Risk Management Consultant Location: Dublin City Centre Salary: Competitive, plus benefits including bonus, healthcare and much more Working Model: Permanent | Hybrid (Travel involved) As Risk Management Consultant you'll play a key role in helping clients identify, assess, and manage enterprise-level risks within the Insurance sector. This is a consultative role, offering practical guidance and support through advisory work, workshop facilitation, the development of risk frameworks and tools, and knowledge-sharing initiatives. You'll collaborate with senior stakeholders to strengthen governance structures, embed risk-aware thinking across teams, and help shape more proactive, agile approaches to risk. This is a fantastic opportunity for someone with a strong risk mindset who enjoys variety, problem-solving, and being part of something meaningful. You'll have direct impact, broad exposure, and the chance to shape better outcomes at scale. Key Responsibilities: Provide expert advice and hands-on support on risk identification, mitigation, and strategy Design and deliver tailored frameworks, tools, and step-by-step guidance for managing risk Facilitate workshops and group sessions to build internal risk capability Present insights and emerging trends at forums, events, or internal working groups Contribute to internal data analysis, reporting, and wider organisational projects Act as a trusted partner to members, promoting stronger risk culture and performance Requirements Strong experience in risk management, risk advisory, or a governance-related role A background in risk advisory, insurance, engineering, information security, health & safety, compliance, legal or similar Strong people skills with a consultative mindset - capable of listening actively, adapting your approach, communicating confidently and managing conversations professionally Ambitious with a can do attidue Experience creating risk management tools, templates, or resources Understanding of frameworks such as ISO 31000, COSO, or similar Full clean driving licence (off-site meetings and travel is a core part of the role) If you are interested please apply via the link or apply directly to Skills: Consultancy Strong people skills Risk Management Benefits: Work From Home
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Director, Quality Risk Management

Dublin, Leinster Bristol Myers Squibb

Posted today

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**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Position Summary**
The Director, Quality Risk Management will drive consistent Global Leadership on Quality Risk Management (QRM), the Risk Management Framework, Risk Posture considerations and provide support for key QRM processes within the GxPs (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP) across the Product Lifecycle. Accountable to drive QRM process optimization, integration, adoption and continuous improvement through capability building, key stakeholder engagement, digital enhancement, trend analysis of QRM data and guidance on authoring QRM procedures. Works cross-functionally to develop performance improvement initiatives throughout the organization by interacting and working with many great teams and leaders across the BMS network.
This position will report into the Senior Director, Risk Management.
**Key Responsibilities:**
+ Provide strategic and tactical leadership for establishing and maintaining robust QRM programs across the BMS QMS Level 1 and 2 processes and sub-processes, end-to-end product lifecycle and across all BMS in alignment with relevant governmental regulations and guidelines.
+ Drive process design, simplification, deployment, maintenance, monitoring and improvement of QRM procedures and methodologies (tools). Provide oversight for the management of all changes being planned and executed in these processes.
+ In partnership with the Senior Director, Risk Management, champion the E2E, across product lifecycle QRM Framework and strategic roadmap.
+ Develop and Drive enhancement on digital QRM mapping. Lead execution digital roadmap.
+ Develop Risk Tolerance statements, risk acceptance statements and guiding principles for BMS QRM related risk posture.
+ Lead Risk identification and risk communication/reporting for governance meetings, such as Quality management reviews and Enterprise Risk Management and support managing emerging risks to support business objectives.
+ Lead and support to teams in implementing risk management capabilities and process elements
+ Provide guidance and coaching for the Risk Management Team.
+ Lead the QRM training framework and certification program design & oversee deployment.
+ Foster a culture of risk awareness, risk informed decision making and proactive risk management throughout the organization and by this enhance QRM maturity.
+ Stakeholder Partnering and Engagement: Lead the partnership with teams across BMS for stakeholder-oriented incorporation/improvement of QRM principles and appropriate risk-based approaches into the business processes of the Quality Management System enterprise-wide.
+ Co-chair with the Senior Director, Risk Management, QRM specific governance and oversight forums.
+ Business support: Drive process monitoring/adoption and GxP risk profiles through overseeing data collection, analysis, trending and reporting of QRM dashboards in collaboration with I&T .
+ Stay updated with industry best practices and regulatory requirements related to QRM communicate within BMS and adapt internal processes effectively.
+ Works across regulator/industry boundaries to become a QRM industry leader, find common solutions, and drive positive impact and benefits for patients.
+ Collaborate with internal and external stakeholders to ensure alignment and compliance with QRM processes.
+ Provide direction and critical input for setting metrics and monitoring and evaluating the effectiveness of QRM initiatives, and recommend improvements as needed.
+ Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses.
+ Oversee the process design for managing major disruptions to the GxP business including how to respond in a Risk Based manner (incorporating QRM principles, tools and processes into the response)
+ Provide leadership, coaching, and training for members of the QRM Community of Practice and other QRM practitioners including both the technical processes and the behaviors necessary to optimize process execution.
+ Support the testing and roll out of IT systems supporting QRM processes and data analytics.
**Qualifications & Experience:**
+ Master's degree in pharmaceutical sciences, engineering, biology, or other related discipline or equivalent combination of education and experience.
+ A minimum of 15 years of biopharmaceutical/pharmaceutical industry experience with at least 3 years in risk management leadership position.
+ Expertise in GMP compliance, Quality System and global GMP regulations
+ Must have strong knowledge and expert understanding using different QRM tools for the different GXP areas (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP).
+ Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
+ Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
+ Demonstrated influential leadership expertise and experience with senior level interactions.
+ Excellent analytical and problem-solving skills, with the ability to identify and mitigate risks effectively
+ Enterprise mindset to be able to think and act across functions and divisions.
+ Ability to work in a fast-paced and dynamic environment, managing multiple priorities simultaneously.
+ Strong leadership and project management skills, with the ability to lead cross-functional teams.
+ Expert-level knowledge and experience using data to drive understanding, decisions, and recommendations.
+ Excellent communication and interpersonal skills, with the ability to collaborate effectively with stakeholders at all levels.
+ Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
+ Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk to deliver value added business results that meet high quality requirements with tight deadlines.
+ Travel: Ability to travel 10-25% as needed
**GPS_2025 GQ_2025**
The starting compensation for this job is a range from $187,700 to $227,400, plus incentive cash and stock opportunities (based on eligibility).
The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.
Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
#LI-Hybrid
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1593133
**Updated:** 2025-07-19 01:44:42.954 UTC
**Location:** Princeton-NJ
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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Risk Management and Controls

Mulhuddart, Leinster Kyndryl

Posted 3 days ago

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Job Description

**Who We Are**
At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward - always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities.
**The Role**
Kyndryl is the world's largest provider of IT infrastructure services.
**Europe Regulatory Office Mission:** Responsible for the implementation, administration, and oversight of a regulatory and governance program supporting our compliance with EU DORA, NIS 2 and UK CTP Regime.
**Job Summary:** Senior Lead, Risk Management and Controls will be responsible for identifying relevant, regulated accounts and onboarding them to our regulatory compliance program. This role involves participating and coordinating governance activities across first, second, and third lines of defense functions ensuring an integrated approach to compliance. Additionally, the role includes performing regular reviews and controls assessments to identify improvements and track progress as well as playing a key role in regulator examinations. The ideal candidate will have strong skills in risk management, communication and IT security control frameworks.
**Key Responsibilities** **:**
+ Account Identification: Identify relevant, regulated customers, using automation where possible, and provide guidance to those account teams in the onboarding process.
+ Governance: Establish, participate and coordinate governance activities across first (Delivery/Accounts), Second (Security Assurance, Business Controls), and Third (Corporate Audit) lines of defense driving alignment and establishing best practices.
+ Reviews and Controls Assessments: Perform regular reviews of governance/risk activities (MSAC, QCM, SOC) as well as ICT security controls assessments. Design improvements where appropriate and track implementation.
+ Risk Management: Develop and implement risk management strategies to mitigate potential threats and vulnerabilities.
+ ICT Security Controls: Leverage knowledge of ICT security control frameworks to enhance security measures on regulated accounts and infrastructure.
+ Collaboration: Work closely with various stakeholders (BC, CAS, CISO, S&R, Delivery) on cohesive risk management practices.
+ Reporting: Develop, prepare and present appropriate compliance metrics and reporting to senior management and exam teams.
**Who You Are**
Qualifications/Skills:
+ Strong understanding of ICT security control frameworks (NIST; ISO 27002)
+ Excellent analytical, and communication skills.
+ 7+ years experience with corporate governance and related activities.
+ Strong understanding of risk management principles and practices.
+ Ability to work collaboratively with cross-functional teams.
Preferred Certifications/experience:
+ Project Management Professional (PMP)
+ Certification in Risk and Information Systems Control (CRISC)
+ Certified Information Security Manager (CISM)
**Being You**
Diversity is a whole lot more than what we look like or where we come from, it's how we think and who we are. We welcome people of all cultures, backgrounds, and experiences. But we're not doing it single-handily: Our Kyndryl Inclusion Networks are only one of many ways we create a workplace where all Kyndryls can find and provide support and advice. This dedication to welcoming everyone into our company means that Kyndryl gives you - and everyone next to you - the ability to bring your whole self to work, individually and collectively, and support the activation of our equitable culture. That's the Kyndryl Way.
**What You Can Expect**
With state-of-the-art resources and Fortune 100 clients, every day is an opportunity to innovate, build new capabilities, new relationships, new processes, and new value. Kyndryl cares about your well-being and prides itself on offering benefits that give you choice, reflect the diversity of our employees and support you and your family through the moments that matter - wherever you are in your life journey. Our employee learning programs give you access to the best learning in the industry to receive certifications, including Microsoft, Google, Amazon, Skillsoft, and many more. Through our company-wide volunteering and giving platform, you can donate, start fundraisers, volunteer, and search over 2 million non-profit organizations. At Kyndryl, we invest heavily in you, we want you to succeed so that together, we will all succeed.
**Get Referred!**
If you know someone that works at Kyndryl, when asked 'How Did You Hear About Us' during the application process, select 'Employee Referral' and enter your contact's Kyndryl email address.
Kyndryl is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics. Kyndryl is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
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Senior Associate, Cyber Security IT Risk Management

Limerick, Munster Northern Trust

Posted today

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Job Description

About Northern Trust: Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring principles of service, expertise, and integrity. With more than 130 years of financial experience and over 22,000 partners, we serve the world's most sophisticated clients using leading technology and exceptional service. Role/ Department: This role is part of Cybersecurity Third Party Risk Management team within 1st Line of Defense; The candidate will be conducting security risk assessment on new and existing Northern Trust's third parties' business partners. Ensuring proper preventative and detective controls are in place and prepare recommendations to strengthen control weaknesses. The candidate will combine deep subject matter expertise in both cybersecurity and assurance disciplines and have exceptional communication and stakeholder management skills. The key responsibilities of the role include: Information Security Governance and Risk Management Access Control Vulnerability and Penetration Network Security Application Security Cryptography Security Architecture and Design Operations Security Business Continuity and Disaster Recovery Planning Legal, Regulations, Investigations and Compliance Physical and Environmental Security Cloud Security Knowledge of regulatory requirements and guidelines relating to Cyber Security, Information Security, Business Resilience and Business Continuity Management. Knowledge on risk treatment and issues management functions and industry tools to support the program. Knowledge of security controls considering factors like data protection, access controls, network segmentation, digital technologies such as Artificial Intelligence (AI) Experience in securing the cloud networking and hybrid configurations. Participate in cyber incident responses to provide guidance related to cyber security risks and control assurance. Foster a positive and collaborative environment. Flexibility, multi-tasking, good business judgment skills are required to meet competing priorities. Contribute to automation, analytics, and continuous improvements of processes. Demonstrate ability to work well in both an individual contributor and team capacity. Skills/ Qualifications: Excellent written and verbal communication skills. Attention to detail. Experience working in global, cross-functional, collaborative teams. In-depth understanding of information security, network management, operating systems, software development, database systems and information technology. Knowledge and awareness on NIST Cyber Security Framework, Center for Internet Security (CIS), ISO etc. is a plus. Knowledge of technology controls around Cloud Computing reviews. Advanced experience with MS Office, SharePoint, and Reporting tools Working with Us: As a Northern Trust partner, greater achievements await. You will be part of a flexible and collaborative work culture in an organization where financial strength and stability is an asset that emboldens us to explore new ideas. Movement within the organization is encouraged, senior leaders are accessible, and you can take pride in working for a company committed to assisting the communities we serve! Join a workplace with a greater purpose. We'd love to learn more about how your interests and experience could be a fit with one of the world's most admired and sustainable companies! Build your career with us and apply today. #MadeForGreater Reasonable accommodation Northern Trust is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please email our HR Service Center at . We hope you're excited about the role and the opportunity to work with us. We value an inclusive workplace and understand flexibility means different things to different people. Apply today and talk to us about your flexible working requirements and together we can achieve greater.
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