Quality Systems Lead — Regulatory Readiness & Inspections

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

Job summary

Vir Biotechnology, Inc. seeks an experienced Temporary Associate Director, Quality Systems (12+ month contract) to oversee the Quality Management System as the company advances regulatory submissions and commercialization readiness.

The role is based in San Francisco, onsite three days per week. You will partner with cross-functional teams to drive core Quality Systems, support inspections, and lead continuous improvement while ensuring compliance with FDA, ICH, and global GMP expectations in

Qualifications

• Bachelor's degree in a scientific discipline.
• Advanced degree preferred.
• 8-10+ years of progressive Quality Assurance experience within the biotechnology, pharmaceutical, or related regulated industry.

Responsibilities

• Provide leadership and oversight for Vir's Quality Management System, ensuring alignment with regulatory requirements and business objectives.
• Oversee core Quality Systems processes, including document control, training, audits, quality events/investigations, 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 continued development and maturity of scalable Quality Systems to support clinical development, regulatory submissions, and commercialization readiness.
• Establish and monitor Quality System metrics and key performance indicators to support management review and continuous improvement.
• Conduct quality system assessments, risk evaluations, and gap analyses to ensure compliant and consistent practices across the organization.
• Lead cross-functional initiatives focused on quality system effectiveness, and continuous improvement.
• Provide quality and compliance guidance while partnering with internal stakeholders and external partners to support business objectives and regulatory commitments.

Skills

Quality Assurance

GMP

Inspection readiness

CAPA

Regulatory knowledge

Risk management

Quality metrics

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Vir Biotechnology, Inc. seeks an experienced Temporary Associate Director, Quality Systems (12+ month contract) to oversee the Quality Management System as the company advances regulatory submissions and commercialization readiness.

The role is based in San Francisco, onsite three days per week. You will partner with cross-functional teams to drive core Quality Systems, support inspections, and lead continuous improvement while ensuring compliance with FDA, ICH, and global GMP expectations in