Associate Director, Quality Control Strategy

Vir-Biotechnology

San Francisco (CA)

Hybrid

USD 163,000 - 228,000

Full time

2 days ago
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Benefits offered by this job

Health benefits
Paid time off
Commuter benefits
401K match
Lunch in office

Job summary

Vir Biotechnology, Inc. is seeking an Associate Director, Technical Operations Quality Control, to lead QC execution and program-level strategy from Phase 1 through commercialization.

You will translate QC strategy into integrated plans, ensuring timely, compliant delivery of release and stability testing, method lifecycle management, and vendor oversight across multiple programs. You will collaborate with Quality, Manufacturing, Regulatory, Analytical Development, and Stability to meet CMC

Qualifications

  • Broad QC leadership across phases from early development to commercialization.
  • Strong knowledge of cGMP, ICH, FDA, EMA expectations.
  • Experience with method lifecycle management and external partner oversight.
  • Ability to lead cross-functional teams and communicate complex technical information clearly.
  • Experience supporting CMC regulatory submissions and inspection readiness.

Responsibilities

  • Translate QC strategy into execution plans for programs and external networks.
  • Lead QC activities across product lifecycle with phase-appropriate control strategies.
  • Develop and refine QC strategies, methods, specifications, and external lab models.
  • Harmonize QC methods, specifications, and documentation across programs and partners.
  • Identify and mitigate risks to QC performance, supply continuity, and regulatory commitments.
  • Represent QC on CMC teams and analytical sub-teams; ensure readiness for milestones.
  • Provide leadership and coaching to QC staff and external partners.
  • Oversee QC operations, release and stability testing at internal and external labs.
  • Review analytical data, batch records, CoAs, and GMP documentation; escalate issues.

Skills

Quality Control
cGMP
Analytical methods
External partner management
Cross-functional collaboration

Education

BA/BS with 12+ years in Biochemistry/Chemistry/Biology/Virology/Engineering
MA/MS/MBA with 10+ years
PhD with 8+ years

Job description

Vir Biotechnology, Inc. is seeking an Associate Director, Technical Operations Quality Control, to lead QC execution and program-level strategy from Phase 1 through commercialization.

You will translate QC strategy into integrated plans, ensuring timely, compliant delivery of release and stability testing, method lifecycle management, and vendor oversight across multiple programs. You will collaborate with Quality, Manufacturing, Regulatory, Analytical Development, and Stability to meet CMC

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