GLP Vendor Oversight and Quality Assurance Lead
On-site · King of Prussia, Pennsylvania, United States
Job Summary
Own quality oversight of external partners supporting nonclinical and GLP activities; lead vendor lifecycle, risk-based qualification, quality agreements, and set vendor KPIs and governance forums, ensuring actions and CAPAs are closed. Identify and prioritize vendors for audit on a risk basis, plan and conduct inspections, and ensure CAPA effectiveness. Ensure vendor practices meet GLP/GCP/GMP, OECD GLP, 21 CFR Part 58, ICH, ISO and data integrity (ALCOA+). Lead vendor risk assessments (risk registers, FMEA) to improve performance and present trends at management reviews. Embed quality requirements in scopes of work and contracts, guide technology transfers and data flows, and train internal stakeholders. Stay current with regulatory frameworks and translate changes into CSL requirements. Travel up to 50%.
Required Qualifications
- Bachelor's degree in a relevant scientific discipline
- 3+ years of GxP quality experience with direct vendor/CRO oversight and/or auditing (GLP/GCP/GMP)
- Knowledge of OECD GLP, 21 CFR Part 58, Annex 11/Part 11 and data integrity (ALCOA+)
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