Senior Manager, Quality Control
Vir Biotechnology, Inc.
8 hours ago
Remote friendly (San Francisco, CA)
United States
Operations
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.
Responsibilities:
- Execute and operationalize QC strategy for assigned programs and external testing networks.
- Lead QC activities across the product lifecycle (Phase 1 through commercial), ensuring phase-appropriate control strategies.
- Develop/refine QC strategies (methods, specifications, testing approaches) with Analytical Development and QC leadership.
- Drive harmonization of QC methods/specifications across programs and external partners.
- Identify, assess, and escalate risks to QC performance, supply continuity, and compliance; implement mitigation plans.
- Represent QC on program teams to ensure analytical deliverables, timelines, and QC readiness for key CMC milestones.
- Manage day-to-day QC operations for timely, compliant clinical and commercial testing.
- Coordinate and oversee release and stability testing; review analytical data and batch records; support CoA generation.
- Lead QC GMP processes (deviations, OOS/OOT, change controls, investigations) with QA.
- Coordinate QC documentation/logistics at external labs (sampling plans, shipments, inventory).
- Manage vendor performance and oversight (CTL/CDMO).
- Execute method lifecycle activities (qualification, transfer, validation, implementation, monitoring).
Qualifications/Skills:
- BA/BS with 10+ years; MA/MS/MBA with 8+ years in biochemistry, chemistry, biology, virology, chemical engineering, or related field (preferred).
- Technical expertise in analytical methods for release/stability testing of monoclonal antibodies.
- Strong QC/assay development background and knowledge of cGMP/ICH/FDA/EMA.
- Experience with analytical test method optimization, validation, transfer, and contract organizations.
Compensation/Eligibility:
- Expected salary range: $142,500–$199,000/year.
- Applicants must be authorized to work in the U.S.; sponsorship is not available.
Responsibilities:
- Execute and operationalize QC strategy for assigned programs and external testing networks.
- Lead QC activities across the product lifecycle (Phase 1 through commercial), ensuring phase-appropriate control strategies.
- Develop/refine QC strategies (methods, specifications, testing approaches) with Analytical Development and QC leadership.
- Drive harmonization of QC methods/specifications across programs and external partners.
- Identify, assess, and escalate risks to QC performance, supply continuity, and compliance; implement mitigation plans.
- Represent QC on program teams to ensure analytical deliverables, timelines, and QC readiness for key CMC milestones.
- Manage day-to-day QC operations for timely, compliant clinical and commercial testing.
- Coordinate and oversee release and stability testing; review analytical data and batch records; support CoA generation.
- Lead QC GMP processes (deviations, OOS/OOT, change controls, investigations) with QA.
- Coordinate QC documentation/logistics at external labs (sampling plans, shipments, inventory).
- Manage vendor performance and oversight (CTL/CDMO).
- Execute method lifecycle activities (qualification, transfer, validation, implementation, monitoring).
Qualifications/Skills:
- BA/BS with 10+ years; MA/MS/MBA with 8+ years in biochemistry, chemistry, biology, virology, chemical engineering, or related field (preferred).
- Technical expertise in analytical methods for release/stability testing of monoclonal antibodies.
- Strong QC/assay development background and knowledge of cGMP/ICH/FDA/EMA.
- Experience with analytical test method optimization, validation, transfer, and contract organizations.
Compensation/Eligibility:
- Expected salary range: $142,500–$199,000/year.
- Applicants must be authorized to work in the U.S.; sponsorship is not available.