Senior Specialist, QA Operations (Temporary) at Vir Biotechnology, Inc. in San Francisco, California, United States

Job description

• 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.

Responsibilities

• 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

Requirements

• 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 preferred
• 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
• Experience working with CMOs, CTLs, or suppliers preferred

Skills

Required

• Organizational skills
• Communication skills
• Collaboration skills
• cGMP regulations
• GMP manufacturing and testing
• Validation protocols and reports
• Supplier quality management

Benefits

• The expected hourly range for this position is $52.00 to $70.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.