Senior CSV & Compliance Lead (Hybrid)

Merck Gruppe - MSD Sharp & Dohme; Dunboyne; Hybrid; EUR 120,000 - 170,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme in Dunboyne, Co. Meath, is seeking an Associate Director of Compliance/CSV Lead to oversee computerized system validation and IT/OT compliance across site operations.

The role involves leading cross-functional teams, managing audits, and driving risk-based remediation within a Biologics/Manufacturing context. The incumbent will ensure adherence to 21 CFR Part 11 and ISA/S88 standards, while coordinating with global quality groups and auditors, and guiding SDLC

Qualifications

• Bachelor’s degree as listed in the HTML.
• 5+ years supporting compliance activities.
• Knowledge of regulatory requirements (21 CFR Part 11, EMEA Annexes 11).
• Ability to manage internal and external auditors/agencies.
• Knowledge of ISA S95 and S88 in a GxP environment.
• Experience validating Cloud, SaaS, analytics, and data integration platforms.
• Understanding of end-to-end manufacturing business processes (Manufacturing, Quality, Supply).
• Strong stakeholder collaboration and clear communication across diverse audiences.
• Strategic, top-down thinking with ambiguity management.
• Experience in Computer Systems Validation, instrumentation/automation, and project management.

Responsibilities

• Lead and/or support site functional structures for computerized system validation and IT/OT compliance.
• Coordinate regional cross-site alignment for validation and IT/OT compliance.
• Ensure supply and quality of all compliance components through planning and SDLC deliverables.
• Represent compliance to internal and external auditors/agencies.
• Develop audit responses and engage with local quality organizations.
• Identify IT/OT compliance risks and remediation.
• Perform risk assessments for new technologies or significant changes.
• Oversee compliance operations in Automation and IT teams.
• Assist local teams with quality and compliance challenges and SOP adherence.
• Report deviations and CAPAs; monitor quality records as control indicators.
• Communicate SDLC policy changes site-wide and share learnings.

Skills

Regulatory compliance

Auditing

SDLC

Data integrity

Project management

21 CFR Part 11

EMEA Annexes 11

Quality systems

ISA S95/S88

Cloud/SaaS validation

GxP knowledge

Cross-functional collaboration

Communication skills

Strategic thinking

Self-directed leadership

Computer Systems Validation

Education

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

Job description

Merck Gruppe - MSD Sharp & Dohme in Dunboyne, Co. Meath, is seeking an Associate Director of Compliance/CSV Lead to oversee computerized system validation and IT/OT compliance across site operations.

The role involves leading cross-functional teams, managing audits, and driving risk-based remediation within a Biologics/Manufacturing context. The incumbent will ensure adherence to 21 CFR Part 11 and ISA/S88 standards, while coordinating with global quality groups and auditors, and guiding SDLC