Director, Risk Based Quality Management

The Director, Risk Based Quality Management will serve as a Lead Subject Matter Expert and Process Owner for assigned areas, processes, and technologies. They will lead collaborations with CRO partners and provide oversight of vendors performing RBQM activities, ensuring alignment with Gilead’s RBQM framework. This role involves supporting inspection-readiness, participating in audits and regulatory inspections, and providing expert guidance, training, and support on RBQM in clinical trials. The Director will advise study teams on risk management, contribute to the development of central monitoring tools, and participate in determining monitoring strategies and mitigation plans. They will also facilitate cross-functional risk review meetings, oversee the timely resolution of risk signals, and lead the development, enhancement, and implementation of RBQM processes, systems, templates, tools, and training materials. Managing RACT libraries, leading or contributing to continuous improvement initiatives, developing and analyzing RBQM performance metrics, and championing change initiatives are also key responsibilities. Additionally, the Director will build and maintain strong partnerships with service providers and represent Gilead in industry-wide collaborations.