Manager, Computer System Validation (CSV), QA

The Manager, Computer System Validation (CSV), QA will report to the Associate Director, Quality Assurance (QA). This position will provide quality oversight of the computer system validation lifecycle from design and implementation to retirement, ensuring compliance of GxP applications. This role will ensure that all GxP computerized systems, including Veeva, Argus, SAP, Tracelink, etc., are implemented, validated, and maintained in compliance with FDA, EMA, ICH, GAMP 5, and other Health Authority requirements. The ideal candidate will combine technical expertise in CSV, strong quality systems acumen, and exceptional cross-functional communication skills.