Quality Assurance Director

Job Summary

To support the development of innovative therapies, the remote Associate Director or Director of Quality Assurance will provide quality oversight across the manufacturing and regulatory approval processes for investigational medicines, ensuring compliance with cGMP requirements and fostering strong relationships with external partners.

Key Responsibilities

• Provide QA oversight of CMO operations, ensuring compliance with protocols, specifications, and cGMP requirements
• Serve as QA lead for deviations, investigations, and change controls, conducting root-cause analysis and product impact assessments
• Build and maintain quality relationships with external partners, supporting audits, regulatory inspections, and submissions

Required Qualifications

• BS or MS in Biology, Chemistry, Engineering, or a related life sciences discipline
• 10+ years of experience in the biotech or pharmaceutical industry, with 5+ years in Quality Assurance oversight roles
• 5+ years of experience managing quality relationships with CMOs
• Strong working knowledge of cGMPs and the drug development lifecycle, including relevant regulatory standards
• Proven project management skills with the ability to drive multiple projects to completion