Senior Director of GMP Quality Assurance
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
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
