Director, QC Product Readiness

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About the role

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.   Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.   We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description   Company Overview Gilead Sciences, Inc. is a biopharmaceutical company committed to advancing innovative medicines that help prevent and treat life-threatening diseases. Our work is grounded in scientific rigor, collaboration, accountability, and a shared commitment to improving the lives of patients. Position Overview The Director, Quality Control Product Readiness leads the organization of QC Leads responsible for assigned commercial products and programs. The role establishes direction, governance, expectations, and resource priorities for the QC Lead function, ensuring consistent oversight of product readiness, analytical lifecycle activities, and transition from clinical to commercial QC. This leader coaches and develops the QC Leads, removes barriers, resolves cross-program issues, and serves as the escalation point in commercial QC. Focus Areas Product Readiness and Portfolio Execution • Oversee clinical-to-commercial QC transitions and ongoing product readiness, ensuring clear criteria, stakeholder alignment, sustainable ownership, and resolution of readiness gaps. • Manage portfolio priorities, testing capacity, resources, and execution risks; escalate systemic issues and sponsor recovery plans to support uninterrupted product supply. • Analytical and Regulatory Lifecycle Oversight • Provide technical guidance and decision frameworks for complex analytical issues, investigations, methods, specifications, reference standards, documentation, and related readiness gaps. • Ensure scientifically sound health authority responses and governance of post-approval changes and regulatory commitments through implementation and closure. Leadership and Cross-Functional Partnership • Build, lead, mentor, and develop a high-performing team of QC Leads responsible for product readiness and analytical lifecycle oversight. • Define the QC Lead operating model, role expectations, decision rights, performance standards, and development pathways. • Ensure appropriate assignment and capacity of QC Leads across the portfolio based on program complexity, risk, and business priorities. • Establish scalable standards, metrics, and continuous improvement practices that strengthen consistency, product readiness, compliance, and execution across the QC Lead organization. • Contribute to department strategy, workforce and resource planning, budgeting, succession planning, and long-range capability development. Qualifications • BS degree with 12+ years of relevant experience, MS degree with 10+ years of relevant experience, or PhD with 2+ years of relevant experience in Chemistry, Biochemistry,

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