Director of Lab Quality Management

Job Summary

A company is looking for a Director of External Lab Quality & Testing Performance.

Key Responsibilities

• Manage quality oversight of external labs performing various testing for 503A and 503B operations
• Ensure compliance with regulatory standards and maintain audit readiness
• Define and track performance metrics for lab operations and facilitate regular performance reviews

Required Qualifications

• Bachelor's or advanced degree in Chemistry, Biology, Pharmaceutical Sciences, or related field
• 8-10 years of experience in a cGMP-regulated quality environment, including leadership in lab or vendor operations
• Direct experience supporting 503A and/or 503B compounding operations
• Strong understanding of relevant FDA cGMP guidelines and USP standards
• Proven success in managing external vendors and implementing performance improvement programs