• Lead GxP system qualification and validation activities for the eQMS, COTS, and TPS. • Develop, execute, and maintain system validation plans, validation reports, UAT scripts, and periodic review records. • Administer and continuously improve eQMS quality event workflows - CAPA, nonconformance records (NCR), deviations, change controls, and document management. • Lead and maintain the Vendor Qualification Program and Third-Party System (TPS) audit schedule. • Lead vendor qualification and audit activities end-to-end. • Apply ALCOA+ data integrity principles across all system records. • Manage system change controls, post-change impact assessments, and revalidation activities. • Identify and escalate GxP system compliance risks; lead root cause analysis and drive CAPA for system-related quality events. • Collaborate with IT and DevOps/QC on software release validation, infrastructure qualification, and integration testing in regulated environments. • Plan, execute, report, and manage follow-up on the internal audit program per established schedule. • Own and maintain the vendor and TPS audit schedule; lead vendor audits, remote desktop reviews, and surveillance assessments.