Associate Director, Quality Assurance Compliance

Role: Associate Director, Quality Assurance Compliance responsible for managing inspection operations, logistics, and readiness activities at Gilead's Foster City site. Objectives include supporting regulatory inspections, maintaining inspection readiness tools, overseeing documentation, and leading global inspection strategies. Responsibilities encompass coordinating site inspections, developing inspection procedures, managing system tools, leading mock inspections, and ensuring compliance with regulations such as FDA, EMA, and ICH standards. The role also involves leveraging digital tools and AI to enhance inspection processes, analyzing quality data for continuous improvement, and supporting audit programs. Requirements: BS/BA in sciences with 8+ to 10+ years' industry experience, or MS/MA with 8+ years, or PhD with 5+ years. Must have biotech/pharma industry background, experience managing health authority inspections, and deep knowledge of GxP regulations. Additional expertise in manufacturing processes (biologics, API, aseptic fill, etc.), digital systems (Veeva, SharePoint), and AI-enabled inspection tools is preferred. The role demands strong leadership, strategic planning, communication skills, and the ability to work independently or within a matrix environment. Travel up to 50% may be required. The position is site-based in Foster City, with flexibility for remote candidates.