Associate Director, Tech Compliance & CSV Lead

Msd Ireland; Dunboyne; Hybrid; EUR 120,000 - 150,000; Full time

Job summary

MSD Ireland is seeking an Associate Director of Compliance/CSV Lead at our Dunboyne site. The role drives CSV/IT-OT compliance across Automation and IT, partnering with stakeholders to ensure policy conformance and quality deliverables.

With 5+ years in compliance roles, you will engage auditors, manage risk, and lead SDLC governance while supporting a dynamic manufacturing environment in Meath.

Qualifications

• Bachelor’s Degree in Computer Science, Engineering, Regulatory compliance, or related field.
• 5+ years supporting compliance activities.
• Regulatory knowledge: 21CFR Part 11, EMEA Annexes 11, etc.
• Experience managing internal and external auditors/agencies.
• Knowledge of ISA S95 and S88 in GxP environments.
• Experience validating Cloud, SaaS, data integration architectures.
• Understanding of end-to-end Manufacturing processes including Quality and Supply.
• Ability to partner with stakeholders across conflicting priorities.
• Strong written and verbal communication skills; capable of clear explanations.

Responsibilities

• Lead and/or support site structures for all CSV and IT/OT compliance issues.
• Coordinate regional cross-site alignment for CSV/IT-OT compliance.
• Deliver SDLC, change control, periodic reviews, CAPAs, audits, and policy deployment.
• Represent compliance to auditors/agencies and support audit responses.
• Identify IT/OT compliance risks and remediation actions.
• Execute risk assessments for new tech and architecture changes.
• Ensure efficient operations of Compliance in Automation and IT teams.
• Collaborate with local teams to meet SOPs and policies.

Skills

Leadership

Communication

Regulatory knowledge

Auditing

GxP understanding

Stakeholder partnering

Strategic thinking

Education

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

Tools

Cloud/SaaS validation

ISA S95/S88

Job description

MSD Ireland is seeking an Associate Director of Compliance/CSV Lead at our Dunboyne site. The role drives CSV/IT-OT compliance across Automation and IT, partnering with stakeholders to ensure policy conformance and quality deliverables.

With 5+ years in compliance roles, you will engage auditors, manage risk, and lead SDLC governance while supporting a dynamic manufacturing environment in Meath.