Senior Manager of Technical QA (GMP)
Summit Therapeutics, Palo Alto, CA (US) +1
What you will do
- Responsible for providing sponsor oversight of clinical Contract Manufacturing Organizations (CMO) and Contract Testing Laboratories (CTLs) to support clinical manufacture and testing.
- Responsible for providing sponsor oversight of Contract Testing Laboratories (CTLs) support clinical and commercial product testing, methods, method transfers, method validations, stability, and specifications.
- Partner with Supplier Quality to monitor quality performance metrics for CMOs, CTLs and critical suppliers, ensuring effective management of quality risks and continuous improvement initiatives.
- Maintain the Annual Product Quality Review process, including trend analysis, product quality assessments, process performance evaluation and management review reporting.
- Collaborate with MSAT and Technical Operations teams for Change Controls of process development, technology transfer, scale-up activities, and other manufacturing and analytical changes and provide quality oversight for the Change Control program while ensuring appropriate impact assessments, risk evaluations, implementation plans and effectiveness verification. Schedule and lead weekly Change Control meetings.