Tech Compliance Lead - IT/OT & CSV

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

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.