Contract Associate Director, Quality Systems

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

Job summary

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

The role partners with cross-functional stakeholders to ensure phase-appropriate, compliant quality systems across the organization. Based in San Francisco with onsite requirement three days per week, you will lead core processes: document control, training,

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• 8-10+ years of progressive Quality Assurance experience within biotech/pharma or related regulated industry.
• Experience leading Quality Systems in a GMP environment with knowledge of FDA regulations, ICH guidelines, global GMP requirements.
• Experience supporting regulatory inspections, inspection readiness programs, audit management, and remediation activities.
• GCP, GVP, GLP, Device experience a bonus.

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
• Coordinate risk management activities
• 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 experience

Regulatory knowledge

Quality Management Systems

Audits & CAPA

Risk management

Cross-functional collaboration

Education

Bachelor's degree in science

Advanced degree preferred

Job description

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

The role partners with cross-functional stakeholders to ensure phase-appropriate, compliant quality systems across the organization. Based in San Francisco with onsite requirement three days per week, you will lead core processes: document control, training,