Menlo Park, CA16 days ago
Role Overview: The Director, Quality Control - Combination Products will provide strategic and operational leadership for the Quality Control function supporting late-stage clinical development, analytical testing oversight for clinical drug substance and drug product, process performance qualification (PPQ), regulatory submissions, and commercial launch readiness for monoclonal antibody drug products and combination products, including pre-filled syringes and autoinjectors. Strong knowledge of cGMP regulations and global regulatory expectations, including 21 CFR Parts 210, 211, and 4. Hands-on experience supporting combination products such as pre-filled syringes, autoinjectors, or related delivery systems.