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...