Found Description
The Opportunity
- Provide quality and compliance oversight of CDMOs, CROs/PET centers, and in‑licensing partners to ensure compliance with cGMP and quality agreement requirements
- Have expertise and experience in the clinical product development lifecycle, production oversight, and release of clinical supply
- Execute all required activities to assess and release clinical supply, including review and approval of specifications, master batch records, methods, method validation reports, and executed batch records
- Lead resolution of complex investigations, changes and risk assessments
- Perform disposition of outsourced investigational medicinal products in SAP, including API and drug product of synthetic molecules and biologics
- Serve as the Quality Point of Contact for CDMOs, CROs and in‑licensing partners, and participate as a key member of cross‑functional management teams to enable site selection, qualification and implementati...