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, improving compliance adherence, inspection readiness, and continuous improvement initiatives across the organization.
You will partner closely with cross-functional stakeholders to ensure Quality Systems continue to be 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 oversight for Vir's Quality Management System, ensuring alignment with regulatory requirements and business objectives
- 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
- Conduct quality system assessments, risk evaluations, and gap analyses to ensure compliant and consistent practices across the organization
- Coordinate risk management activities
- 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
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 GMP environment,.
- Demonstrated expertise in Quality Management Systems, including document control, training, audits, CAPA, quality events, investigations, change control, risk management, and quality metrics
- 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
- GCP, GVP, GLP, Device experience a bonus
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.
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Skills Required
- Bachelor's degree in a scientific discipline
- Advanced degree
- 8-10+ years of progressive Quality Assurance experience in biotechnology, pharmaceutical, or a related regulated industry
- Experience leading and managing Quality Systems in a GxP environment
- Expertise in document control, training, audits, CAPA, investigations, change control, risk management, and quality metrics
- Knowledge of FDA regulations, ICH guidelines, global GxP requirements, and quality system expectations for late-stage development and commercialization
- Experience supporting regulatory inspections, inspection readiness programs, audit management, and remediation activities
- Ability to lead complex cross-functional initiatives and influence stakeholders across organizational levels
What We Do
Vir Biotechnology, Inc. (in Europe, Humabs BioMed, https://bit.ly/46lQGN2) is an immunology company focused on powering the immune system to address unmet patient needs in infectious disease and beyond. Our powerful R&D engine combines our proprietary monoclonal antibody (mAb) platform with machine learning and artificial intelligence-enhanced capabilities, enabling us to engineer our rich database of human antibodies and deliver transformative medicines for diseases with significant global burden. Our current pipeline consists of multiple clinical candidates targeting hepatitis B and hepatitis delta viruses and human immunodeficiency virus, including a potential functional cure for chronic hepatitis B and treatment for chronic hepatitis delta. Our portfolio of broad, potent investigational monoclonal antibodies also targets influenza A and B viruses, COVID-19, respiratory syncytial virus/human metapneumovirus and human papillomavirus, and our investigational T cell vaccine aims to prevent HIV. Explore our full pipeline: https://bit.ly/3tr7FPm We collaborate with some of the world’s leaders in industry as well as government agencies and non-profit organizations enabling us to rapidly advance cutting-edge scientific discoveries and innovative technologies with the potential to benefit people around the world. We are proud to have been ranked the fastest-growing company in North America on the 2022 Deloitte Technology Fast 500™. Join us as we pursue our mission to transform lives. It has come to our attention that there have been various recruitment scams targeting job seekers on LinkedIn. Vir Biotechnology, Inc. is committed to your privacy and will never request sensitive personal information including banking details through email, text message, social media or video software platforms. We also will never request a financial commitment from a candidate as part of the application process. Learn more about Vir’s recruiting process: https://bit.ly/461EgJN
