Senior Manager, Quality Control

Vir Biotechnology, Inc. is a clinical‑stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Senior Manager, Technical Operations Quality Control The Senior Manager, Technical Operations Quality Control, is responsible for executing and operationalizing QC strategy across assigned programs and external testing partners (e.g., CDMOs/CTLs) from Phase 1 through commercialization. This role ensures the timely and compliant delivery of QC activities, including release and stability testing, method lifecycle management, and vendor oversight. The Senior Manager partners cross‑functionally with Quality, Technical Operations, Regulatory, and Analytical Development to deliver program milestones, maintain inspection readiness, and support global regulatory submissions. This individual contributes to the development of QC strategy and drives continuous improvement in QC processes, systems, and external network performance. The role is located in our San Francisco headquarters with an expectation of 3 days per week in office. Responsibilities Execute and operationalize QC strategy for assigned programs and external testing networks in alignment with QC and Quality organization strategy. Lead QC activities across the product lifecycle (Phase 1 through commercial) for designated programs, ensuring effective implementation of phase‑appropriate control strategies. Support development and refinement of QC strategies, including methods, specifications, and testing approaches, in collaboration with Analytical Development and QC leadership. Drive consistent execution and harmonization of QC methods, specifications, and practices across programs and external partners. Identify, assess, and elevate risks to QC performance, supply continuity, and compliance, and implement mitigation plans with cross‑functional stakeholders. Represent QC on program teams and sub‑teams, ensuring alignment of analytical deliverables, timelines, and QC readiness for key CMC milestones. Manage day‑to‑day execution of QC operations to ensure timely, compliant testing for clinical and commercial programs. Coordinate and oversee release and stability testing (including CDMOs/CTLs), including review of analytical data, batch records, and supporting documentation; support CoA generation. Lead execution of QC GMP processes (deviations, OOS/OOT, change controls, investigations) in collaboration with QA. Coordinate QC documentation and logistics at external labs, including sampling plans, shipments, and reagent/inventory management. Manage vendor performance and execution, including CTL/CDMO oversight and routine operational interactions. Execute method lifecycle activities (qualification, transfer, validation, implementation, and monitoring) across internal and external labs. Qualifications BA/BS with 10+ years experience or MA/MS/MBA with 8+ years experience in Biochemistry, Chemistry, Biology, Virology, Chemical Engineering or a related discipline (preferred). Technical expertise in a wide range of analytical methods for release and stability testing of monoclonal antibodies. Strong scientific background in Quality Control and/or assay development in the biotech industry with strong knowledge of cGMP/ICH/FDA/EMA regulations. Expertise with analytical test method optimization, validation, and transfer as well as working with contract organizations. Compensation & Benefits Salary range: $142,500 to $199,000 per year. Full‑time employees receive a package that includes compensation, bonus and equity; health and welfare benefit plans; non‑accrual paid time off; company shutdown for holidays; commuter benefits; 401K match; lunch each day in the office. Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. All employment decisions at Vir Biotechnology are based on legitimate, non‑discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment. Vir Biotechnology participates in E‑Verify for hires based in the United States. #J-18808-Ljbffr Vir-Biotechnology