Manager, Quality Operations

Role: Senior Manager/Associate Director, Quality Operations overseeing pharmaceutical manufacturing, testing, validation, and supply for both clinical and commercial products. Responsibilities: provide strategic quality leadership, ensure compliance with global cGMP standards, review GMP documentation, lead investigations and validation activities, oversee audits of external partners, develop quality metrics, and collaborate cross-functionally with teams such as CMC, Regulatory, and Clinical Operations. Qualifications: Bachelor's or Master's in science, engineering, pharmacy, or related field; 6+ years in pharmaceutical or biotech quality assurance. Skills: deep understanding of manufacturing, analytical testing, validation, and global regulations (e.g., 21 CFR, EU GMP, ICH); experience with batch record review, deviation management, CAPA, change control, and supplier oversight; ability to lead audits, influence stakeholders, and manage complex issues. Preferred: experience with inspection readiness, quality systems, and proficiency with electronic quality management tools; strong analytical and communication skills. HighValue: expertise in pharmaceutical quality systems, cGMP compliance, validation, and cross-functional collaboration within regulated environments. WorkSetup: hybrid role based in Redwood City, California, with up to 20% travel.