Associate Director, Technology Compliance

About the role

A fantastic opportunity has arisen for an Associate Director of Technology Compliance at MSD's state‑of‑the‑art facility in Dunboyne, Co. Meath. The role combines leadership of computerized system validation, IT/OT compliance and cross‑functional collaboration to ensure high‑quality biologics manufacturing.

Key responsibilities

• Lead and support site and regional structures for computerized system validation and IT/OT compliance issues.
• Ensure supply and quality of compliance components through tactical planning and execution of SDLC deliverables, change‑control, periodic reviews, system administration, disaster recovery, deviations, CAPA, audits, cyber security and data integrity.
• Represent compliance activities to internal and external auditors and develop audit responses.
• Execute risk assessments for new technologies and manage remediation of IT/OT compliance risks.

Required profile

• Bachelor’s degree in Computer Science, Engineering, Regulatory Compliance or a related field.
• Minimum 5 years of experience supporting compliance activities in a pharmaceutical manufacturing environment.
• Demonstrated ability to work with internal and external auditors and navigate cross‑functional priorities.

Required skills

• Computer System Validation (CSV)
• 21 CFR Part 11 and EMEA Annex 11 compliance
• ISA S95 and ISA S88 standards
• Cloud/SaaS validation and modern analytics
• Data integration architecture
• Project Management
• Instrumentation/Automation & Control
• Real‑time shop‑floor integration
• Manufacturing analytics and supply‑demand forecasting