Product Quality Director

Role: Product Quality Director overseeing product quality for Amgen’s biopharmaceuticals, focusing on late-phase and commercial biologics across Oncology, Inflammation, and Rare Disease areas. Responsibilities: lead cross-functional product quality activities—including process validation, stability, comparability, specifications, and regulatory filings; provide scientific oversight; manage a Product Quality Team; and collaborate with global quality, manufacturing, regulatory, and development units. Requirements: Doctorate with 4+ years or Master’s with 7+ years or Bachelor’s with 9+ years in Quality, Operations, or Scientific roles; expertise in biologics, analytical techniques, and GMP regulations; 8+ years pharma experience; 6+ years in regulated environments; 2+ years as a PQL or similar role; strong leadership and communication skills. Preferred: advanced biotech degree; experience with protein/small molecule analysis, regulatory submissions, and project management; knowledge of drug substance and product development, stability programs, and risk assessment. High-value specifics: biologics (large molecules), late-stage and commercial products, regulatory submissions, global GMP compliance, cross-functional leadership, and staff management. Work setup: flexible, with a focus on leadership in a regulated, innovative biotech environment.