Senior Director of QA Operations

Job Summary

A company is looking for a Senior Director of Quality Assurance Operations.

Key Responsibilities

• Provide enterprise-level leadership for QA Operations supporting clinical and commercial cell and gene therapy programs
• Serve as the primary QA point of accountability for external CMOs, CDMOs, and other GxP service providers
• Drive process optimization, digital enablement, and standardization across QA Operations

Required Qualifications

• Bachelor's degree in a scientific or engineering discipline; advanced degree preferred
• 15+ years of progressive experience in Quality Assurance within biotech or pharmaceutical environments
• Demonstrated experience supporting clinical and commercial manufacturing, preferably in cell and gene therapy
• Deep knowledge of global GxP regulations and expectations, including FDA, EMA, and ICH
• Proven track record of leading QA oversight of external manufacturing and testing partners