Specialist, Quality Operations

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 Bio is looking for a Temporary Senior Specialist, Quality Operations (12+ Month Initial Contract) who will support quality oversight activities related to manufacturing, testing, packaging, and labeling operations at Vir Biotechnology and Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), and suppliers. This individual will partner with cross-functional teams to help ensure products are manufactured, tested, and released in compliance with current Good Manufacturing Practices (cGMPs) and applicable regulatory requirements.

You will contribute to quality review and approval activities, support issue management and investigations, and help maintain quality systems that support clinical and commercial products across our development portfolio.

This role is based in our San Francisco, California office with the expectation to be onsite three days per week.

WHAT YOU'LL DO

• Support quality oversight of manufacturing, testing, packaging, and labeling activities performed by CMOs, CTLs, and suppliers
• Review quality records including deviations, CAPAs, change controls, investigations, and SOPs
• Review manufacturing and testing documentation, including batch records and supporting release documentation
• Support batch disposition and release activities
• Review validation protocols and reports, including process, method, and cleaning validation activities
• Collaborate with cross-functional teams to address quality issues and support ongoing operations
• Assist with supplier quality management activities and Quality Agreement maintenance
• Support internal audits, supplier audits, and regulatory inspection readiness activities
• Escalate quality issues and compliance risks to management as appropriate
• Contribute to continuous improvement initiatives within the Quality organization

WHO YOU ARE AND WHAT YOU BRING