Associate Director, Quality Systems (Temporary)

Vir-Biotechnology; San Francisco (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Vir Biotechnology, Inc. seeks an Associate Director, Quality Systems (Temporary) to provide oversight of the Quality Management System as the company advances regulatory submissions, commercialization readiness, and portfolio growth.

The role partners with cross-functional teams to ensure phase-appropriate, compliant quality systems and drives continuous improvement. This role is onsite in San Francisco three days per week.

Qualifications

• 8-10+ years of progressive Quality Assurance within biotech/pharma.
• Experience leading Quality Systems in GMP environments.
• Strong knowledge of FDA, ICH, GMP and QA metrics.
• Experience supporting regulatory inspections and remediation activities.

Responsibilities

• Provide leadership for Vir's Quality Management System ensuring regulatory alignment.
• Oversee core Quality Systems: document control, training, audits, CAPA, change control, risk management, complaints, metrics.
• Support inspection readiness and regulatory inspections, internal and partner audits.
• Develop and mature scalable Quality Systems for clinical development and commercialization readiness.
• Establish and monitor Quality System metrics to drive continuous improvement.
• Conduct risk evaluations and gap analyses to ensure compliant practices.
• Lead cross-functional initiatives focused on qualitySystem effectiveness.
• Provide guidance to internal and external stakeholders to meet regulatory commitments.

Skills

Quality Assurance

GMP

Quality Systems

FDA regulations

Regulatory inspections

CAPA

Change control

Education

Bachelor's degree in science

Job description

Associate Director, Quality Systems (Temporary)

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
• 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 .

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Vir Biotechnology’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A \"disabled veteran\" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A \"recently separated veteran\" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An \"active duty wartime or campaign badge veteran\" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An \"Armed forces service medal veteran\" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.