Director Product Quality Leader

Job description preview

From AstraZeneca’s original posting

The Cell Therapy Product Quality Leader (PQL) is a matrixed leader responsible for the end-to-end product quality strategy and lifecycle management of autologous, allogeneic, and in-vivo cell therapy products. This role will provide technical and compliance oversight for advanced therapeutic modalities, including, but not limited to, drug substance, drug product, viral delivery systems (e.g. LVV, AAV), and gene-edited cell therapy products from clinical stage through commercialization. This role requires deep technical and compliance expertise, strategic thinking, and cross-functional collaboration to ensure product quality, regulatory compliance, and lifecycle continuity are met and maintained. This PQL position can physically reside at either the Gaithersburg/Rockville, MD site or Santa Monica/Tarzana, CA site locations, with an understanding that the products supported are manufactured at the Santa Monica/Tarzana, CA sites. Main Responsibilities: • Serve as the Quality representative on the CMC Team and lead the Product Quality Team (PQT) sub-team • Serve as the single voice of Quality in liaising with the CMC Program Lead to communicate Quality deliverables, risks, changes,…