Senior Specialist, QA Operations (Temporary)

The role

This person will support quality oversight for manufacturing, testing, packaging, and labeling operations at Vir Biotechnology and its partners. They will partner with cross-functional teams to ensure products comply with cGMP and regulatory requirements.

What you will 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

Required qualifications

• Experience supporting GMP manufacturing and testing activities
• Familiarity with quality systems including deviations, CAPAs, change controls, investigations, and document management
• Working knowledge of cGMP regulations and quality principles
• Strong organizational, communication, and collaboration skills

Nice to have

• Bachelor's degree in a scientific discipline and 5+ years of experience in Quality Assurance, Quality Operations, Manufacturing, or a related GMP-regulated pharmaceutical or biotechnology environment
• Experience working with CMOs, CTLs, or suppliers

Before you apply

• 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.
• Vir Biotechnology participates in E-Verify

About the company

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.