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. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.
Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.
THE OPPORTUNITY
The Associate Director, Technical Operations Quality Control, leads QC execution and program-level strategy across assigned programs and external testing partners (e.g., CDMOs/CTLs) from Phase 1 through commercialization. This role translates QC strategy into integrated execution plans and ensures timely, compliant delivery of QC activities, including release and stability testing, method lifecycle management, reference standard and critical reagent oversight, and vendor performance management.
The Associate Director partners cross-functionally with Quality, Technical Operations, Manufacturing, Regulatory, Analytical Development, and Stability to deliver CMC milestones, maintain inspection readiness, and support global regulatory submissions. This individual provides technical and operational leadership across multiple programs, may manage or mentor QC colleagues, and drives continuous improvement in QC processes, systems, and external network performance.
This role is located in our San Francisco headquarters with an expectation of 3 days per week in office.
WHAT YOU'LL DO
- Translate and implement QC strategy for assigned programs and external testing networks in alignment with QC, Quality, and Technical Operations objectives.
- Lead QC activities across the product lifecycle (Phase 1 through commercial) for multiple programs, ensuring phase-appropriate control strategies and timely execution of analytical deliverables.
- Lead development and refinement of QC strategies, including methods, specifications, testing approaches, and external laboratory execution models, in collaboration with Analytical Development and QC leadership.
- Drive consistent execution and harmonization of QC methods, specifications, practices, and documentation across programs and external partners.
- Identify, assess, and escalate risks to QC performance, supply continuity, regulatory commitments, and compliance; develop and drive mitigation plans with cross-functional stakeholders.
- Represent QC as a program lead on CMC teams, program teams, and analytical sub-teams, ensuring alignment of QC deliverables, timelines, and readiness for key CMC milestones.
- Provide leadership, coaching, and technical guidance to QC colleagues and external partners; may directly manage employees or consultants supporting QC execution.
- Oversee QC operations to ensure timely, compliant testing for clinical and commercial programs, including release and stability testing performed internally and at CDMOs/CTLs.
- Oversee review of analytical data, batch records, CoAs, and supporting GMP documentation; ensure issues are appropriately evaluated, documented, and escalated.
- Lead or oversee QC GMP processes, including deviations, OOS/OOT, change controls, investigations, CAPAs, and related impact assessments in collaboration with QA.
- Manage CTL/CDMO performance and routine operational interactions, including governance meetings, issue resolution, metrics review, and accountability for agreed deliverables.
- Lead method lifecycle activities, including qualification, transfer, validation, implementation, optimization, and ongoing performance monitoring across internal and external laboratories.
- Partner with Analytical Development to support method development, comparability or bridging studies, assay trending, and lifecycle management of release and stability specifications for drug substance and drug product.
- Oversee reference standards, assay controls, and critical reagents used in QC, ensuring appropriate characterization, qualification, availability, and fit-for-purpose use across internal and external labs.
- Support QC contributions to regulatory filings and health authority responses, including method validation, specification justification, stability-related content, and inspection readiness materials.
- Serve as a QC subject matter expert during audits, technical visits, due diligence activities, and health authority inspections.
- Drive continuous improvement initiatives across QC processes, systems, vendor oversight, data review practices, and external network performance.
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WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $162,500 to $227,500 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir Biotechnology's compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes compensation, bonus and equity as well as many other Vir Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, 401K match and lunch each day in the office.
