Senior Manager Quality Assurance
Vir Biotechnology (Vir), a San Francisco based company focused on infectious diseases seeks a Senior Manager, Quality Assurance to support the manufacture and analysis of Drug Substance and Drug Products at Contract Manufacturing Organizations (CMOs) and labeling of clinical and commercial supplies and analysis of finished products at Contract Research Organizations (CROs) to ensure Vir’s drugs are in compliance with Good Manufacturing Practices (GMP) and are of the appropriate quality for their intended use. You will have quality oversight of CMOs/CROs and liaison of quality related issues with Vir’s Chemistry, Manufacturing and Control (CMC) and Clinical Teams and functional management. The scope of the position encompasses oversight of all aspects of drug manufacture through clinical development and into commercial phase.
The successful incumbent will be the QA Representative on CMC and non-clinical teams responsible for drug manufacture, testing, labeling, and non-clinical activities. The position will require regular interaction with the VP of QA at both the CMOs/CROs and Vir on matters concerning the product quality and CMO/CRO GMP compliance. This may include, but is not limited to:
- Responsible for QA operational oversight of CMO/CRO’s and suppliers.
- Interaction with CMO/CRO senior leaders to assure that Vir QA / GMP interests are met and that relationships are properly maintained.
- Accompany CMC and non-clinical on technical visits when required.
- Review and approve Master Batch Record (MBR) in compliance with GMP regulations, regulatory filings and quality agreements.
- Review and approval of executed batch records, analytical raw data, stability protocols, reports and data, and other documents to enable drug substance and final drug product release and on-going evaluation certifying batches as GMP compliant.
- Review and approval of validation protocols, raw data, and reports (Method, Process, Cleaning).
- Manage change control, deviation, and investigation processes in place at Vir and the oversight of such systems at the CMO/CRO.
- Review and approval of changes, deviations, and investigations at CMOs/CROs.
- Management of the batch release process at VIR including issuance of COR’s.
- Collaborates with the Senior Director of QA Compliance on quality system reviews and gap analyses as part of CMO/CRO selection, approval, and on-going evaluation.
- Serves as back-up to compliance group to conduct GMP compliance audits of contractors and suppliers.
- Review CMC and non-clinical sections of regulatory filings.
- Provide support in the preparation for and during governmental regulatory agency inspections of Vir and Vir’s contractors.
- Develop, refine and manage internal Vir Quality Operation Systems as appropriate to the phase of development.
- Develop and maintain product trending analysis and metrics. Present Metrics and associated findings in annual management reviews and reports.
QUALIFICATIONS AND EXPERIENCE:
- 8+ years’ experience in QA oversight of pharmaceutical development manufacturing and testing.
- Knowledge of large molecule manufacturing and analytical testing.
- Practical knowledge of cGMPs and GLPs and an ability to apply sound judgment and decision-making skills (risk based and appropriate for the phase of clinical development).
- Working knowledge of US, Health Canada, and EU cGMP regulations and guidelines.
- Strong planning and time management skills and ability to prioritize own work.
- Strong leadership and influencing skills.
- Experience in auditing suppliers, CMOs, CROs, and clinical sites.
- Experience with drug substance and drug product manufacturing and testing QA oversight.
- Experience with QA oversight of manufacturing and testing of both Clinical Trial Materials (CTM) and Commercial Products.
- Experience in auditing suppliers, CMOs and CROs.
- Some travel required (10-15%) domestic and international.
- Bachelor degree in chemistry, biology, microbiology, industrial pharmacy or other related scientific discipline.