Senior Director of GMP Quality Assurance

Job Summary

A company is looking for a Senior Director, GMP QA.

Key Responsibilities

• Develop and oversee the global GMP QA strategy for the company's portfolio
• Provide leadership and mentorship to the quality system team and collaborate on CMC-related quality activities
• Monitor CDMO and vendor performance, ensuring compliance and timely resolution of quality issues

Required Qualifications

• Bachelor's or Master's degree in Life Sciences, Engineering, or a related scientific discipline
• Over 15 years of experience in quality assurance roles within the pharmaceutical industry
• In-depth knowledge of cGMP regulations and experience with batch record reviews
• Proven track record in managing quality activities at CDMOs and developing GMP audit programs
• Strong leadership skills with experience in regulatory inspections and customer audits