Key skills
Risk Management
About this role
Role Overview
- Lead quality oversight of outsourced clinical and manufacturing operations supporting cell therapy programs from patient collection through product administration
- Establish and maintain a robust supplier quality management program
- Oversee GxP compliance across external partners
- Drive quality risk management and inspection readiness
- Partner cross-functionally to ensure reliable and safe product supply across various programs
Requirements
- Quality oversight for GxP Partners, Suppliers & service providers (CDMOs, CROs, central laboratories, apheresis centers, logistics providers, and clinical sites)