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Vir Biotechnology is a clinical-stage biopharmaceutical company developing medicines for serious infectious diseases and cancer, leveraging the PRO-XTEN® masking platform for dual-masked T-cell engagers and other immunotherapies.
As Associate Director of Quality Control, you will lead QC execution and strategy across multiple programs from Phase 1 through commercialization, managing both internal operations and external testing partners (CDMOs/CTLs). This is a leadership role with cross-functional scope and potential direct reports.
Key responsibilities include:
- Translating QC strategy into integrated execution plans for assigned programs
- Leading QC activities across the product lifecycle, ensuring phase-appropriate control strategies and timely analytical deliverables
- Developing and refining QC strategies, methods, specifications, and testing approaches in collaboration with Analytical Development
- Driving harmonization of QC methods, specifications, and documentation across programs and external partners
- Identifying, assessing, and escalating risks to QC performance, supply continuity, and regulatory compliance
- Representing QC on CMC teams and program teams, ensuring alignment of deliverables and readiness for key milestones
- Providing technical leadership, coaching, and guidance to QC colleagues and external partners; may directly manage employees or consultants
- Overseeing QC operations including release and stability testing, data review, batch records, and GMP documentation
- Leading QC GMP processes including deviations, OOS/OOT investigations, change controls, and CAPAs
- Managing CDMO/CTL performance, governance meetings, metrics review, and accountability
- Leading method lifecycle activities including qualification, transfer, validation, and optimization
- Overseeing reference standards, assay controls, and critical reagents across internal and external labs
- Supporting regulatory filings, health authority responses, and inspection readiness
- Serving as QC subject matter expert during audits, technical visits, and inspections
- Driving continuous improvement initiatives across QC processes and vendor oversight
The role is based in San Francisco headquarters with an expectation of 3 days per week in office.
