Teams at MSD Animal Health Technology Labs

Provides IT compliance and validation support for computerized systems at a biologics manufacturing site. Responsibilities include CSV and SDLC compliance, data integrity, cybersecurity controls, change controls, periodic reviews, access administration, disaster recovery, incident investigations, CAPAs, audit support, training, and inspection readiness. The role serves as a subject matter expert and liaison for auditors while supporting regulatory compliance under GxP, EU Annex 11, 21 CFR Part 11, GMP, and SOX requirements.

Ensures computerized systems, data management processes, and system development activities comply with GxP, CSV, data integrity, cybersecurity, and regulatory requirements. Manages validation and compliance activities, including change controls, periodic reviews, access management, disaster recovery, deviations, CAPAs, audits, inspections, and training. Serves as a compliance and validation subject matter expert while maintaining continuous inspection readiness across a biologics manufacturing site.

Lead a multi-site laboratory Quality Management System across the UK, Ireland, and United States. Harmonize quality procedures, documentation, audits, CAPA, accreditation activities, change management, and continuous improvement. Monitor quality metrics, manage auditor relationships, apply risk-based principles, and coach site Quality Representatives. Requires international collaboration and 15–20% travel.