Vir Biotechnology
Associate Director, Quality Systems (Temporary)
San Francisco, California, United States · Director · Contract
No sponsorship$80k-$109kDetected 32 days ago
GCPHRIntellectual PropertyGMPFDA RegulatoryAnimal StudiesLeadership
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odds of building a lasting career here
47Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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About the role
- This individual will play a critical role in strengthening quality system governance, improving compliance adherence, inspection readiness, and continuous improvement initiatives across the organization.
- This role is based in our San Francisco, California office with the expectation to be onsite three days per week.
Responsibilities
- Oversee core Quality Systems processes, including document control, training, audits, quality events/investigations, CAPA, change control, risk management, product quality complaints, and quality metrics
- Support inspection readiness activities and support regulatory inspections, internal audits, and partner audits
- Assist with the continued development and maturity of scalable Quality Systems to support clinical development, regulatory submissions, and commercialization readiness
- Establish and monitor Quality System metrics and key performance indicators to support management review and continuous improvement
- Lead cross-functional initiatives focused on quality system effectiveness, and continuous improvement
- Provide quality and compliance guidance while partnering with internal stakeholders and external partners to support business objectives and regulatory commitments
- 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.
- You will partner closely with cross-functional stakeholders to ensure Quality Systems continue to be phase-appropriate, compliant and aligned with evolving business needs.
- Demonstrated expertise in Quality Management Systems, including document control, training, audits, CAPA, quality events, investigations, change control, risk management, and quality metrics
Requirements
- 8-10+ years of progressive Quality Assurance experience within the biotechnology, pharmaceutical, or related regulated industry
- Experience leading and managing Quality Systems in a GMP environment,.
- Strong knowledge of FDA regulations, ICH guidelines, global GMP requirements, and quality system expectations supporting late-stage development and commercialization
- Experience supporting regulatory inspections, inspection readiness programs, audit management, and remediation activities
Nice to have
- advanced degree preferred.
- Bachelor's degree in a scientific discipline
Compensation
- This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs.
Benefits
- GCP, GVP, GLP, Device experience a bonus
Company info
- The expected hourly range for this position is $80.00 to $109.00 per hour.
- Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
- 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.
- This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs.
- Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
- Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology.
- Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes.
- We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
- For hires based in the United States, Vir Biotechnology, participates in E-Verify.
- Vir Biotechnology has exclusive rights to the universal PRO-XTEN ® masking platform for oncology and infectious disease.
- 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.
Visa & Work Authorization
- 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.
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This listing is sourced directly from Vir Biotechnology's careers page and normalized into a canonical job model.