Assoc. Dir , Technology Compliance

MSD; Dunboyne; Hybrid; EUR 120,000 - 170,000; Full time

Job summary

MSD in Dunboyne, Co. Meath, seeks an Associate Director of Compliance/CSV Lead to drive validation, regulatory compliance, and audit readiness across the site.

You will lead IT/OT compliance, coordinate with regional teams, manage SDLC controls, and champion data integrity and cyber security within a manufacturing environment. You will collaborate with auditors, improve processes, and ensure conformance with SOPs while guiding cross-functional teams to deliver high-quality biologics

Qualifications

• Bachelor’s degree in a relevant field with strong regulatory exposure.
• Minimum 5 years supporting compliance activities in a regulated setting.
• Knowledge of CFR 21 Part 11, EMEA Annex 11 and related UC compliance.
• Experience managing internal and external audits and inspections.
• Familiarity with ISA S95/S88 in GxP environments.
• Proven ability to validate Cloud, SaaS, and data integration architectures.

Responsibilities

• Lead and/or support site-wide validation and IT/OT compliance initiatives.
• Align regional cross-site activities for CS/CSV compliance.
• Deliver SDLC deliverables, change control, CAPAs, and audits.
• Interact with auditors/agencies and develop audit responses.
• Identify IT/OT compliance risks and remediate them.
• Manage continuous improvement of compliance operations within Automation and IT.
• Report deviations, CAPAs, and performance to quality leadership.

Skills

Regulatory compliance

CSV/QA validation

Audit management

SDLC/IT controls

Data integrity

GxP experience

Risk assessment

Cyber security

SDLC policy knowledge

Cross-site collaboration

Education

Bachelor’s Degree in Computer Science/Engineering/Regulatory compliance

Tools

ISA S95

ISA S88

Cloud/SaaS validation

Data integration platforms

Job description

Job Description

A fantastic opportunity has arisen for a Associate Director of Compliance/CSV Lead at our site in Dunboyne, Co. Meath.

Job Description

A fantastic opportunity has arisen for a Associate Director of Compliance/CSV Lead at our site in Dunboyne, Co. Meath. Our facility in Dunboyne is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility supports seamless connection and collaboration within and across teams and functions. Our Dunboyne facility provides Biologics Drug Substance manufacturing for Clinical Supply, Registration, and Commercial Launch.

Associate Director of Compliance/CSV Lead

Bring energy, knowledge, and innovation to carry out the following

• Lead and/or support various site functional and cross-functional structures for all computerized system validation and IT/OT compliance issues.
• Lead and/or support regional cross-site alignment for all computerized system validation and IT/OT compliance issues.
• Ensure supply and quality of all compliance components required to deliver high-quality products through tactical planning and execution of project and compliance deliverables, including SDLC deliverables, change-control, periodic reviews, performance monitoring, system administration, access administration, disaster recovery, deviations, incident problem management/investigations, CAPAs, audits, policy deployment, cyber security, data integrity, EHS, training, etc.
• Represent compliance activities to internal and external auditors/agencies.
• Support the development of audit responses and engage with local quality organizations on proper strategies when required.
• Identify and engage in remediation of IT/OT compliance risks.
• Execute risk assessments to evaluate the implementation of new technologies or significant changes to existing architectures and technologies.
• Accountable for the effective and efficient running of all compliance operations in the Automation and IT teams.
• Support local teams with quality and compliance challenges and executions on how to comply with SOPs and/or policies.
• Report challenges in execution or adherence to procedural trends due to nonconformance.
• Report status for local/site-based deviations/CAPAs and other quality records that will be used as indicators of control and conformance to policy.
• Communicate and champion changes to the SDLC policies and procedures at the site.
• Engage as a member of a compliance group that shares knowledge and learnings for better execution and conformance to SOP within the Digital Manufacturing Division.
• Liaise with Compliance teams from other sites to ensure consistency and best practices applied.

What Skills You Need

• Bachelor’s Degree in Computer Science, Engineering, Regulatory compliance, or a related study.
• 5+ years supporting compliance activities.
• Proficient and demonstrated knowledge of regulatory requirements (21CFR part 11, EMEA Annex’s 11, etc.) that apply to computerized systems validation and compliance for site-based as well as divisional and enterprise systems.
• Demonstrated ability to manage internal and external auditors/agencies.
• Working knowledge and application of ISA S95 and S88 Standards in GxP environment.
• Working knowledge of how to validate/qualify Cloud, SaaS, modern analytics, and data integration architecture platforms and components.
• Good understanding of end-to-end Manufacturing business processes and value streams inclusive of Manufacturing, Quality, and Supply chain.
• Demonstrated ability to partner with stakeholders and navigate across conflicting priorities to balance critical tactical and strategic needs.
• Outstanding written and verbal communication skills – able to effectively communicate complex concepts in simple ways.
• Demonstrated ability to effectively collaborate and communicate with a variety of audiences and stakeholders including executive management, business leaders, IT peers, and colleagues worldwide.
• Strategic thinker, with demonstrated ability to work in a broad and top-down manner with a fair amount of ambiguity.
• Results-orientation with the proven ability and reputation for developing plans and implementing them successfully.
• Self-directed, self-motivated, focused leader who with little direction can fill in the gaps as to what is needed, and drive expected results.
• Technical, operational, and business expertise in the following disciplines Computer Systems Validation, Instrumentation/Automation & Control, Project Management.
• Prior experience in the pharmaceutical industry, with specific experience in the Manufacturing, Supply Chain, and Manufacturing Quality areas – ideally involving cross-industry collaboration to drive best practices.
• Experience in integrating real-time shopfloor and lab systems, at an enterprise level, with appropriate levels of resiliency and performance.
• Experience in manufacturing analytics systems, including supply and demand forecasting, biologics process modeling, and advanced image analysis.
• Exposure to multiple technologies and processing environments.
• Knowledge of business process re-engineering principles and processes.
• Strong understanding of application development methodologies.

As a company, we are committed in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing talented, and committed people together. The fastest way to breakthrough innovation is when ideas come together in an inclusive environment

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. So, if you are ready to Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology,

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Required Skills

Audit Management, Change Management, Code of Federal Regulations Title 21, Computer System Validation (CSV), Data Integrity, Project Management Leadership, Regulatory Compliance, Risk Assessments, Software Development Life Cycle (SDLC), Validation, Verification and Validation (V&V)

Preferred Skills

Business Processes, Quality Management, Quality Management Systems (QMS)

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

Yes

Hazardous Material(s)

No

Job Posting End Date

10/7/2026

• A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R417202