Quality Systems Leader for Regulatory Readiness

Vir-Biotechnology; San Francisco (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Vir Biotechnology, Inc. seeks an Associate Director, Quality Systems (Temporary) to provide oversight of the Quality Management System as the company advances regulatory submissions, commercialization readiness, and portfolio growth.

The role partners with cross-functional teams to ensure phase-appropriate, compliant quality systems and drives continuous improvement. This role is onsite in San Francisco three days per week.

Qualifications

• 8-10+ years of progressive Quality Assurance within biotech/pharma.
• Experience leading Quality Systems in GMP environments.
• Strong knowledge of FDA, ICH, GMP and QA metrics.
• Experience supporting regulatory inspections and remediation activities.

Responsibilities

• Provide leadership for Vir's Quality Management System ensuring regulatory alignment.
• Oversee core Quality Systems: document control, training, audits, CAPA, change control, risk management, complaints, metrics.
• Support inspection readiness and regulatory inspections, internal and partner audits.
• Develop and mature scalable Quality Systems for clinical development and commercialization readiness.
• Establish and monitor Quality System metrics to drive continuous improvement.
• Conduct risk evaluations and gap analyses to ensure compliant practices.
• Lead cross-functional initiatives focused on qualitySystem effectiveness.
• Provide guidance to internal and external stakeholders to meet regulatory commitments.

Skills

Quality Assurance

GMP

Quality Systems

FDA regulations

Regulatory inspections

CAPA

Change control

Education

Bachelor's degree in science

Job description

Vir Biotechnology, Inc. seeks an Associate Director, Quality Systems (Temporary) to provide oversight of the Quality Management System as the company advances regulatory submissions, commercialization readiness, and portfolio growth.

The role partners with cross-functional teams to ensure phase-appropriate, compliant quality systems and drives continuous improvement. This role is onsite in San Francisco three days per week.