Director, Quality Compliance and Audits

Role: Director of Quality Compliance and Audits (QCA) at Gilead, responsible for leading the global GMP and GDP audit program, ensuring compliance across manufacturing and supply networks including internal facilities, external partners, and third-party vendors. Core responsibilities include managing and developing a team of auditors, establishing risk-based audit plans, conducting and supporting GMP/GDP audits across multiple modalities (small molecules, biologics, medical devices), and driving continuous quality improvement. The role entails partnering with cross-functional teams to identify, escalate, and resolve compliance issues, leveraging digital tools and AI solutions to enhance audit effectiveness, and providing expert guidance on regulatory expectations. Required qualifications are a BS/BA in sciences with at least 12 years (or MS with 10 years) of biopharma industry experience, GMP/GDP auditing expertise, and experience managing audit teams. Preferred skills include experience with regulatory inspections, knowledge of global regulations and inspection practices, and prior exposure to health authorities. The position involves approximately 30% travel and reports to the Executive Director, Quality Compliance & Audits. High-value specifics include GxP compliance, global regulatory standards, and oversight of diverse modalities within a pharmaceutical manufacturing context.