Quality Systems Leader – Inspections & Compliance

Vir Biotechnology; San Francisco (CA); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

Vir Biotechnology is seeking an experienced Associate Director, Quality Systems (Temporary) to oversee the Quality Management System during regulatory submissions and commercialization readiness. The role emphasizes governance, inspection readiness, and continuous improvement across the organization, with a focus on scalable quality processes and metrics.

The position is based in San Francisco with onsite work three days per week, offering a competitive hourly rate and exposure to a fast-paced

Formación

• 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.
• Experience leading and managing Quality Systems in a GxP environment.
• Demonstrated expertise in Quality Management Systems, including document control, training, audits, CAPA, investigations, change control, risk management, and quality metrics
• Strong knowledge of FDA regulations, ICH guidelines, global GxP requirements, and quality system expectations supporting late-stage development and commercialization
• Experience supporting regulatory inspections, inspection readiness programs, audit management, and remediation activities
• Proven ability to lead complex cross-functional initiatives and influence stakeholders across all levels of the organization

Responsabilidades

• Provide leadership and governance for Vir's Quality Management System
• Oversee core Quality Systems processes including document control, training, audits, CAPA, investigations, change control, risk management, and quality metrics
• Lead inspection readiness activities and support regulatory inspections, internal audits, and partner audits
• Drive continued development and maturity of scalable Quality Systems for clinical development, regulatory submissions, and commercialization readiness
• Establish and monitor Quality System metrics and KPIs to support management review and continuous improvement
• Conduct quality system assessments, risk evaluations, and gap analyses to ensure compliant practices across the organization
• Lead cross-functional initiatives focused on quality system effectiveness, operational excellence, and continuous improvement
• Provide quality and compliance guidance while partnering with internal stakeholders and external partners

Conocimientos

Quality Systems

GxP Experience

Audits

CAPA Management

Change control

Documentation control

Regulatory knowledge

Risk management

Cross-functional leadership

Quality metrics

Educación

Bachelor's degree in a scientific discipline

Advanced degree preferred

Descripción del empleo

Vir Biotechnology is seeking an experienced Associate Director, Quality Systems (Temporary) to oversee the Quality Management System during regulatory submissions and commercialization readiness. The role emphasizes governance, inspection readiness, and continuous improvement across the organization, with a focus on scalable quality processes and metrics.

The position is based in San Francisco with onsite work three days per week, offering a competitive hourly rate and exposure to a fast-paced