Associate Director, Quality Systems (Temporary)
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What you'll do
- Provide leadership and governance for Vir's Quality Management System, ensuring alignment with regulatory requirements and business objectives
- Oversee core Quality Systems processes, including document control, training, audits, CAPA, investigations, change control, risk management, and quality metrics
- Lead inspection readiness activities and support regulatory inspections, internal audits, and partner audits
- Drive 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
- Conduct quality system assessments, risk evaluations, and gap analyses to ensure compliant and consistent practices across the organization
- Lead cross-functional initiatives focused on quality system effectiveness, operational excellence, and continuous improvement
- Provide quality and compliance guidance while partnering with internal stakeholders and external partners to support business objectives and regulatory commitments
What they're looking for
- Bachelor's degree in a scientific discipline
- 8-10+ years of progressive Quality Assurance experience within the biotechnology, pharmaceutical, or related regulated industry
- Experience leading and managing Quality Systems in a GxP environment.
- Demonstrated expertise in Quality Management Systems, including document control, training, audits, CAPA, investigations, change control, risk management, and quality metrics
- Strong knowledge of FDA regulations, ICH guidelines, global GxP requirements, and quality system expectations supporting late-stage development and commercialization
- Experience supporting regulatory inspections, inspection readiness programs, audit management, and remediation activities
- Proven ability to lead complex cross-functional initiatives and influence stakeholders across all levels of the organization
Nice to have
- Advanced degree preferred.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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
Vir Biotechnology is seeking an experienced Temporary Associate Director, Quality Systems (12+ month initial contract) to provide oversight of the company's Quality Management System (QMS) as Vir Bio advances towards regulatory submissions, commercialization readiness, and growth of its development portfolio. This individual will play a critical role in strengthening quality system governance, inspection readiness, and continuous improvement initiatives across the organization.
You will partner closely with cross-functional stakeholders to ensure Quality Systems are scalable, phase-appropriate, compliant, and aligned with evolving business needs. This role will provide strategic oversight of core Quality Systems processes, drive quality culture initiatives, and support the ongoing maturation of our quality infrastructure in preparation for health authority inspections and commercial operations.
This role is based in our San Francisco, California office with the expectation to be onsite three days per week.
WHAT YOU'LL DO
- Provide leadership and governance for Vir's Quality Management System, ensuring alignment with regulatory requirements and business objectives
- Oversee core Quality Systems processes, including document control, training, audits, CAPA, investigations, change control, risk management, and quality metrics
- Lead inspection readiness activities and support regulatory inspections, internal audits, and partner audits
- Drive 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
- Conduct quality system assessments, risk evaluations, and gap analyses to ensure compliant and consistent practices across the organization
- Lead cross-functional initiatives focused on quality system effectiveness, operational excellence, and continuous improvement
- Provide quality and compliance guidance while partnering with internal stakeholders and external partners to support business objectives and regulatory commitments
WHO YOU ARE AND WHAT YOU BRING
- Bachelor's degree in a scientific discipline; advanced degree preferred.
- 8-10+ years of progressive Quality Assurance experience within the biotechnology, pharmaceutical, or related regulated industry
- Experience leading and managing Quality Systems in a GxP environment.
- Demonstrated expertise in Quality Management Systems, including document control, training, audits, CAPA, investigations, change control, risk management, and quality metrics
- Strong knowledge of FDA regulations, ICH guidelines, global GxP requirements, and quality system expectations supporting late-stage development and commercialization
- Experience supporting regulatory inspections, inspection readiness programs, audit management, and remediation activities
- Proven ability to lead complex cross-functional initiatives and influence stakeholders across all levels of the organization
WHO WE ARE AND WHAT WE OFFER
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.
Company
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