Associate Director, Quality Control
Vir Biotechnology, Inc.
August 22, 2026
Remote friendly (San Francisco, CA)
United States
Operations
Associate Director, Technical Operations Quality Control
What You’ll Do
- Translate and implement QC strategy for assigned programs and external testing networks (CDMOs/CTLs) aligned with QC/Quality/Technical Operations objectives.
- Lead QC activities across the product lifecycle (Phase 1 through commercial) for multiple programs, ensuring phase-appropriate control strategies and timely analytical deliverables.
- Develop/refine QC strategies (methods, specifications, testing approaches, and external execution models) with Analytical Development and QC leadership.
- Drive harmonization of QC methods/specifications/practices/documentation across programs and partners.
- Identify/escalate QC performance, supply, regulatory, and compliance risks; develop mitigation plans.
- Represent QC on CMC/program teams; align QC deliverables and readiness for key CMC milestones.
- Provide leadership/coaching; may manage/mentor QC colleagues and external partners.
- Oversee QC operations for timely, compliant release/stability testing (internal and outsourced).
- Oversee GMP documentation review (analytical data, batch records, CoAs); manage deviations, OOS/OOT, change controls, investigations, CAPAs with QA.
- Manage CTL/CDMO performance (governance, metrics, issue resolution).
- Oversee method lifecycle (qualification/transfer/validation/implementation/optimization/ongoing monitoring).
- Oversee reference standards and critical QC reagents.
- Support regulatory filings/health authority responses and serve as QC SME for audits/technical visits.
- Drive continuous improvement across QC processes and external network performance.
Who You Are and What You Bring
- BA/BS (12+ yrs), MA/MS/MBA (10+ yrs), or PhD (8+ yrs) in Biochemistry, Chemistry, Biology, Virology, Chemical Engineering, or related field (preferred).
- Technical expertise in analytical methods for biologics release/stability (e.g., mAbs, recombinant proteins).
- Strong knowledge of cGMP, ICH, FDA, and EMA; QC and/or assay development background.
- Experience with analytical method optimization, qualification, validation, transfer, implementation, and lifecycle management.
- Experience overseeing external partners (CDMOs/CTLs) in an outsourced model.
- Experience supporting CMC regulatory submissions, health authority responses, audit/inspection readiness.
- Strong communication; ability to assess risk, prioritize across programs, and execute in a matrixed environment.
Location: San Francisco headquarters; 3 days/week in office.
Compensation/Benefits
- Expected salary range: $162,500–$227,500/year; includes compensation, bonus and equity plus benefits (health/welfare plans, non-accrual PTO, holiday shutdown, commuter benefits, 401K match, and lunch in office).
Application Instructions
- Applicants must be authorized to work in the U.S.; company cannot sponsor or assume sponsorship of an employment visa at this time.
What You’ll Do
- Translate and implement QC strategy for assigned programs and external testing networks (CDMOs/CTLs) aligned with QC/Quality/Technical Operations objectives.
- Lead QC activities across the product lifecycle (Phase 1 through commercial) for multiple programs, ensuring phase-appropriate control strategies and timely analytical deliverables.
- Develop/refine QC strategies (methods, specifications, testing approaches, and external execution models) with Analytical Development and QC leadership.
- Drive harmonization of QC methods/specifications/practices/documentation across programs and partners.
- Identify/escalate QC performance, supply, regulatory, and compliance risks; develop mitigation plans.
- Represent QC on CMC/program teams; align QC deliverables and readiness for key CMC milestones.
- Provide leadership/coaching; may manage/mentor QC colleagues and external partners.
- Oversee QC operations for timely, compliant release/stability testing (internal and outsourced).
- Oversee GMP documentation review (analytical data, batch records, CoAs); manage deviations, OOS/OOT, change controls, investigations, CAPAs with QA.
- Manage CTL/CDMO performance (governance, metrics, issue resolution).
- Oversee method lifecycle (qualification/transfer/validation/implementation/optimization/ongoing monitoring).
- Oversee reference standards and critical QC reagents.
- Support regulatory filings/health authority responses and serve as QC SME for audits/technical visits.
- Drive continuous improvement across QC processes and external network performance.
Who You Are and What You Bring
- BA/BS (12+ yrs), MA/MS/MBA (10+ yrs), or PhD (8+ yrs) in Biochemistry, Chemistry, Biology, Virology, Chemical Engineering, or related field (preferred).
- Technical expertise in analytical methods for biologics release/stability (e.g., mAbs, recombinant proteins).
- Strong knowledge of cGMP, ICH, FDA, and EMA; QC and/or assay development background.
- Experience with analytical method optimization, qualification, validation, transfer, implementation, and lifecycle management.
- Experience overseeing external partners (CDMOs/CTLs) in an outsourced model.
- Experience supporting CMC regulatory submissions, health authority responses, audit/inspection readiness.
- Strong communication; ability to assess risk, prioritize across programs, and execute in a matrixed environment.
Location: San Francisco headquarters; 3 days/week in office.
Compensation/Benefits
- Expected salary range: $162,500–$227,500/year; includes compensation, bonus and equity plus benefits (health/welfare plans, non-accrual PTO, holiday shutdown, commuter benefits, 401K match, and lunch in office).
Application Instructions
- Applicants must be authorized to work in the U.S.; company cannot sponsor or assume sponsorship of an employment visa at this time.