Biologics QA Director: Strategy & Inspections

Kelly; San Francisco (CA); On-site; USD 210,000 - 250,000; Full time

Job summary

Kelly Science & Clinical is seeking a Director of Quality Assurance for a direct hire at the San Jose, CA site. This strategic role leads Quality Operations, Quality Systems, and CMC Quality oversight across the site and interfaces with global leadership, customers, and regulators.

The incumbent will ensure GMP compliance, inspection readiness, and continuous improvement, partnering with Manufacturing, Regulatory Affairs, and Technical Operations to deliver compliant, patient-ready therapies.

Qualifications

• Bachelor's degree in science or engineering required.
• 10+ years in QA/QA leadership in pharma/biotech.
• Experience with GMP, regulatory submissions (IND/BLA) is preferred.
• Proven track record leading inspections and audits.
• Strong quality and regulatory compliance mindset.

Responsibilities

• Lead site quality strategy and operations.
• Oversee QMS, deviations, CAPAs, change controls.
• Manage regulatory inspections and client audits.
• Direct QA for manufacturing, CMC, and product quality.
• Develop talent and build high-performing team.
• Collaborate with cross-functional partners to enable product delivery.

Skills

Quality Leadership

Regulatory Affairs

GMP Knowledge

Quality Systems

Inspection Readiness

CMC Quality Oversight

Education

Bachelor's degree in Science or Engineering

Master's degree or Ph.D. advantageous

Job description

Kelly Science & Clinical is seeking a Director of Quality Assurance for a direct hire at the San Jose, CA site. This strategic role leads Quality Operations, Quality Systems, and CMC Quality oversight across the site and interfaces with global leadership, customers, and regulators.

The incumbent will ensure GMP compliance, inspection readiness, and continuous improvement, partnering with Manufacturing, Regulatory Affairs, and Technical Operations to deliver compliant, patient-ready therapies.