Teams at Vir Biotechnology

Provides strategic leadership and governance for the company’s Quality Management System in a GxP environment. Oversees document control, training, audits, CAPA, investigations, change control, risk management, and quality metrics. Leads inspection readiness, regulatory inspections, audit management, remediation, quality assessments, and continuous improvement initiatives supporting clinical development, regulatory submissions, and commercialization readiness.

Supports quality oversight for pharmaceutical and biotechnology manufacturing, testing, packaging, and labeling activities at internal and external partners. Reviews deviations, CAPAs, change controls, investigations, SOPs, batch records, validation documents, and release materials. Assists with batch disposition, supplier quality management, audits, regulatory inspection readiness, quality agreements, issue escalation, and continuous improvement while ensuring cGMP and regulatory compliance.

Support clinical and commercial stability programs for biologics by coordinating external studies, reviewing and trending stability data, managing LIMS data and metadata, supporting investigations and protocol documentation, and preparing reports for internal teams and regulatory submissions. The role collaborates with Analytical Development, Quality, Regulatory, Supply Chain, CDMOs, CLOs, and other external partners.