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
The Associate Director, Quality Control - Biologics QC Lead provides strategic Quality Control leadership for assigned biologics programs across the product lifecycle. The role serves as the primary QC representative and partners with internal and external stakeholders such as Analytical Development, Quality Assurance, Regulatory Affairs.
The Associate Director establishes phase-appropriate QC and analytical strategies that enable clinical development, technology transfer, process validation, regulatory submission, commercialization, and lifecycle management while ensuring scientifically sound, compliant, and executable control strategies.
Job Responsibilities:
Serve as the QC Lead and primary Quality Control point of contact for assigned biologics programs; represent QC on product teams and governance forums and provide clear, risk-based recommendations to support program decisions.
Develop and maintain phase-appropriate, end-to-end QC strategies for biologic drug substance, drug product, intermediates, and relevant materials, integrating specifications, analytical methods, sampling, release, stability, reference standards, and critical reagents.
Own or provide senior oversight of specifications and analytical methods.
Provide QC oversight for testing performed at internal laboratories, CMOs/CDMOs, and contract testing laboratories; establish governance, expectations, metrics, escalation pathways, and sustainable testing-network strategies.
Provide scientific and quality guidance for significant deviations, OOS/OOT or atypical results, method-performance issues, stability trends, comparability questions, and laboratory investigations.
Provide QC subject-matter expertise for CMC regulatory content, health-authority questions and interactions, inspections, and readiness activities related to analytical methods, specifications, validation, stability, and QC operations.
Lead cross-program initiatives that strengthen QC governance, specification and control-strategy practices, analytical lifecycle management, procedures, templates, standard work, and appropriate harmonization across modalities.
Lead, coach, and develop QC professionals and matrix teams.
Support departmental strategy, portfolio and resource prioritization, operating plans, budget management, and selection and oversight of external laboratories, consultants, and technical service providers.
This position is based in Foster City, California. Ability to travel domestically and internationally, as needed, to support internal sites, external partners, program activities, and regulatory or inspection-readiness needs.
Ability to work effectively across global teams and time zones and to manage multiple programs, priorities, and critical milestones.
Basic Requiremen ts
Ph.D. with 2+ years experience OR M.S. with 8+ years experience OR…