Assoc. Dir , Technology Compliance

Merck · Dunboyne, Ireland

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Role summary

Associate Director of Compliance and CSV Lead role at a biologics manufacturing facility in Dunboyne, Ireland. Responsible for leading computerized system validation, IT/OT compliance, and regulatory adherence across site and regional operations while supporting quality and compliance initiatives.

What they're looking for

Bachelor's degree in Computer Science, Engineering, Regulatory Compliance, or related field
5+ years supporting compliance activities in regulated environments
Proficient knowledge of 21 CFR Part 11 and EMEA Annex 11 regulatory requirements
Demonstrated ability to manage internal and external audits and regulatory agencies
Working knowledge of ISA S95 and S88 standards in GxP environments
Experience validating Cloud, SaaS, modern analytics, and data integration platforms
Pharmaceutical manufacturing industry experience with cross-functional collaboration skills

What you'll be doing

Lead site and cross-site computerized system validation and IT/OT compliance programs
Execute tactical planning and delivery of compliance, SDLC, change control, and audit activities
Represent compliance to internal and external auditors and regulatory agencies
Identify, assess, and remediate IT/OT compliance risks and non-conformances
Champion SDLC policy changes and support local teams on compliance execution

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Date posted6 days ago

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