Assoc. Dir , Technology Compliance

Merck; Ireland; On-site; EUR 120,000 - 160,000; Full time

Job summary

Merck seeks an Associate Director of Compliance/CSV Lead at its Dunboyne, Co. Meath site. The role leads IT/OT compliance, CIS validation, and cross-site data integrity initiatives within a dynamic, manufacturing-focused environment.

You will interact with auditors and global stakeholders, shaping SDLC policy deployment. Ideal candidates bring 5+ years in compliance roles, strong regulatory knowledge, and a proven track record in cross-functional leadership and manufacturing analytics.

Qualifications

• Bachelor degree or equivalent in a relevant field.
• Minimum 5+ years in compliance support roles.
• Solid grasp of regulatory requirements applicable to computerized systems validation.
• Ability to manage internal and external auditors.
• Familiarity with ISA S95 and S88 in GxP environments.
• Experience validating Cloud/SaaS and data integration platforms.
• Knowledge of end-to-end manufacturing processes including supply chain.

Responsibilities

• Lead and/or support site structures for CIS validation and IT/OT compliance.
• Coordinate cross-site alignment for validation and compliance issues.
• Ensure compliance deliverables across SDLC, change control, audits, CAPAs, data integrity.
• Interface with auditors and regulatory agencies as required.
• Drive risk assessments for new tech changes and architectures.
• Oversee compliance operations within Automation and IT teams.
• Guide local teams on SOPs and policy adherence.

Skills

Regulatory compliance knowledge

Auditors management

ISA S95/S88 familiarity

Cloud/SaaS/data integration validation

Manufacturing process understanding

Stakeholder collaboration

Excellent written and verbal comms

Cross-functional leadership

SDLC and QA practices

Project management

Pharmaceutical industry experience

Real-time shopfloor and lab systems

Education

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

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.

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