Tech Compliance Director & CSV Lead

MSD Malaysia; Dunboyne; Hybrid; EUR 140,000 - 170,000; Full time

Job summary

Merck & Co., Inc. in Dunboyne, Meath, Ireland, seeks an Associate Director of Compliance/CSV Lead to steer computerized system validation and IT/OT compliance for Biologics Manufacturing.

You will drive SDLC, change control, audits, CAPAs, and data integrity while coordinating with auditors and cross-site teams. The role requires 5+ years in compliance, strong regulatory knowledge (21 CFR Part 11, EMEA Annexes), and a track record in cross-functional leadership and risk management within a GMP

Qualifications

• Bachelor's degree in Computer Science, Engineering, Regulatory compliance, or related field.
• 5+ years supporting compliance activities.
• Regulatory requirements knowledge for computerized systems validation (e.g., 21 CFR Part 11, EMEA Annexes).
• Experience with internal and external audits and cross-site collaboration.
• Ability to translate complex concepts for diverse audiences.

Responsibilities

• Lead and/or support site validation and IT/OT compliance across programs.
• Manage SDLC, change control, audits, CAPAs, and data integrity efforts.
• Coordinate with auditors, regulators, and cross-functional teams.
• Assess and mitigate IT/OT compliance risks with new technologies.
• Ensure effective running of compliance operations within Automation and IT teams.

Skills

Audit Management

Regulatory Compliance

CSV

Risk Assessments

SDLC

Data Integrity

Project Management

GxP Knowledge

Education

Bachelor's degree in Computer Science or related

Regulatory or CSV certification

Tools

ISA S95

21 CFR Part 11

Job description

Merck & Co., Inc. in Dunboyne, Meath, Ireland, seeks an Associate Director of Compliance/CSV Lead to steer computerized system validation and IT/OT compliance for Biologics Manufacturing.

You will drive SDLC, change control, audits, CAPAs, and data integrity while coordinating with auditors and cross-site teams. The role requires 5+ years in compliance, strong regulatory knowledge (21 CFR Part 11, EMEA Annexes), and a track record in cross-functional leadership and risk management within a GMP