Senior Compliance & CSV Lead – IT/OT SDLC

MSD Malaysia; Dunboyne; Hybrid; EUR 110,000 - 150,000; Full time

Job summary

Merck & Co., Inc. is seeking an Associate Director of Compliance/CSV Lead for our Dunboyne site in Co. Meath.

The role drives computerized system validation and IT/OT compliance, partnering with regional teams to align SDLC policies and ensure audit readiness across global operations. You will oversee risk assessments, change control, data integrity initiatives, and CAPAs, while collaborating with auditors and cross-functional stakeholders to maintain compliance across manufacturing and quality

Qualifications

• Bachelor's degree in a relevant field and 5+ years supporting compliance activities.
• Proficient knowledge of regulatory requirements (21 CFR Part 11, EMEA Annex 11).
• Experience managing internal and external auditors and agencies.

Responsibilities

• Lead and/or support site CS validation and IT/OT compliance issues.
• Coordinate cross-site alignment for compliance and SDLC deliverables.
• Manage risk assessments for new technologies and significant changes.
• Represent compliance to auditors and agencies.
• Champion data integrity, security, and CAPA processes.

Skills

Regulatory compliance

IT/OT systems

Audits & regulatory inspections

CSV / CS validation

SDLC / Change control

Education

Bachelor's degree in Computer Science, Engineering, or Regulatory compliance

Job description

Merck & Co., Inc. is seeking an Associate Director of Compliance/CSV Lead for our Dunboyne site in Co. Meath.

The role drives computerized system validation and IT/OT compliance, partnering with regional teams to align SDLC policies and ensure audit readiness across global operations. You will oversee risk assessments, change control, data integrity initiatives, and CAPAs, while collaborating with auditors and cross-functional stakeholders to maintain compliance across manufacturing and quality