Temporary Senior QA Ops Specialist – cGMP Oversight

Vir-Biotechnology; San Francisco (CA); On-site; USD 72,000 - 96,000; Full time

Job summary

Vir Biotechnology is seeking a Temporary Senior Specialist, QA Operations in San Francisco, CA. The role focuses on quality oversight across manufacturing, testing, packaging and labeling activities at Vir and partner CMOs/CTLs, ensuring compliance with cGMP and regulatory requirements.

Onsite presence is expected three days per week. You will review quality records, support investigations and issue management, and help maintain quality systems for clinical and commercial products.

Qualifications

• Bachelor's degree in a scientific discipline with 5+ years in QA/Quality Operations or GMP-regulated environment.
• Experience supporting GMP manufacturing and testing activities.
• Familiar with deviations, CAPAs, change controls, investigations, and document management.
• Working knowledge of cGMP regulations and quality principles.

Responsibilities

• Support quality oversight of manufacturing, testing, packaging, and labeling activities 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 release docs.
• Assist with batch disposition and release activities.
• Review validation protocols and reports (process, method, cleaning).
• Collaborate with cross-functional teams to address quality issues.
• Assist supplier quality management and Quality Agreement maintenance.
• Support internal and supplier audits and regulatory inspection readiness.
• Escalate quality issues and compliance risks to management.

Skills

Quality Assurance

GMP

Documentation

Cross-functional

Audits

Education

Bachelor's degree in life sciences

Job description

Vir Biotechnology is seeking a Temporary Senior Specialist, QA Operations in San Francisco, CA. The role focuses on quality oversight across manufacturing, testing, packaging and labeling activities at Vir and partner CMOs/CTLs, ensuring compliance with cGMP and regulatory requirements.

Onsite presence is expected three days per week. You will review quality records, support investigations and issue management, and help maintain quality systems for clinical and commercial products.