Senior Director, GxP Audit & Supplier Quality

4D Molecular Therapeutics; United States; Teletrabalho; USD 156 000 - 179 000; Tempo integral

Resumo da oferta

4D Molecular Therapeutics is seeking a Sr. Manager of Audit and Supplier Management to lead the GxP audit program and manage supplier quality. You will coordinate audits, review deliverables, and drive CAPA/EC activities with cross-functional partners.

The role requires 8+ years in regulated environments, GMP/GCP knowledge, and strong QA systems experience in biotech. Travel ~5% and on-site work in the United States.

Qualificações

• GxP quality experience in biotech or regulated industry.
• Experience leading QA audits and supplier qualification.
• Strong knowledge of GMP and GCP requirements.

Responsabilidades

• Oversee audit programs for clinical sites, internal processes, and vendors.
• Coordinate audit schedules, reviews, and CAPA/EC closure.
• Develop QA metrics for leadership reviews.

Conhecimentos

GxP QA oversight

Audit program management

CAPAs & ECs

GMP/GCP knowledge

Quality Management Systems

Cross-functional collaboration

Formação académica

BS/BA in science or related life science

Ferramentas

GxP QMS software

QA audit tools

Descrição da oferta de emprego

4D Molecular Therapeutics is seeking a Sr. Manager of Audit and Supplier Management to lead the GxP audit program and manage supplier quality. You will coordinate audits, review deliverables, and drive CAPA/EC activities with cross-functional partners.

The role requires 8+ years in regulated environments, GMP/GCP knowledge, and strong QA systems experience in biotech. Travel ~5% and on-site work in the United States.