Associate Director, Quality Systems (Temporary)

The role

This person will provide oversight of the Quality Management System. They will strengthen quality system governance, improve compliance, and support inspection readiness.

What you will do

• Provide leadership and oversight for the Quality Management System
• Oversee core Quality Systems processes including document control, training, audits, CAPA, change control, risk management, product quality complaints, and quality metrics
• Support inspection readiness activities and support regulatory inspections, internal audits, and partner audits
• Assist with the development and maturity of scalable Quality Systems
• Establish and monitor Quality System metrics and key performance indicators
• Conduct quality system assessments, risk evaluations, and gap analyses
• Coordinate risk management activities
• Lead cross-functional initiatives focused on quality system effectiveness and continuous improvement
• Provide quality and compliance guidance to internal stakeholders and external partners

Required qualifications

• Bachelor's degree in a scientific discipline
• 8-10+ years of progressive Quality Assurance experience within the biotechnology, pharmaceutical, or related regulated industry
• Experience leading and managing Quality Systems in a GMP environment
• Expertise in Quality Management Systems including document control, training, audits, CAPA, quality events, investigations, change control, risk management, and quality metrics
• Strong knowledge of FDA regulations, ICH guidelines, global GMP requirements, and quality system expectations supporting late-stage development and commercialization
• Experience supporting regulatory inspections, inspection readiness programs, audit management, and remediation activities

Nice to have

• Advanced degree
• GCP, GVP, GLP, Device experience

Before you apply

• Applicants must currently be authorized to work for any employer in the U.S.
• 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 discovering and developing medicines for serious infectious diseases and cancer.