Director of CMC Quality Assurance

Job Summary

A company is looking for a Director, CMC Quality Assurance.

Key Responsibilities

• Build and enhance the CMC quality management system, ensuring scalability through commercial launch
• Oversee quality assurance for CDMOs and contract testing laboratories, including audits and quality agreements
• Lead PAI readiness activities and serve as QA lead during FDA inspections and regulatory interactions

Required Qualifications

• BS, MS, or PhD in Pharmaceutical Sciences, Chemistry, Biology, or related life sciences; advanced degree preferred
• 15+ years of experience in pharmaceutical or biotechnology quality assurance, with significant experience in senior CMC QA roles
• Experience building CMC quality systems from the ground up
• Deep knowledge of FDA GMP regulations, ICH guidelines, and quality risk management principles
• Experience with small molecule OSD and managing CDMOs from a QA perspective