Senior Manager Quality Assurance

A company is looking for a Senior Manager External Quality. Key Responsibilities: Build and integrate quality systems with external partners and ensure compliance with GMP and FDA standards Provide oversight and leadership to a team of Quality Assurance professionals and drive continuous improvement initiatives Ensure smooth manufacturing operations and compliance at the external manufacturing site, including review of batch documentation Required Qualifications: Bachelor's degree in pharmacy, pharmaceutical sciences, chemistry, or biology is required Minimum of 8 years of experience in a regulated environment, preferably in pharmaceutical, medical device, or biotech quality settings Experience in external manufacturing, technology transfers, and quality system development Demonstrated ability to manage a team and provide cGMP compliance support Position requires living near the FDBN site

Apr 10, 2025 - 20:46

A company is looking for a Senior Manager External Quality. Key Responsibilities: Build and integrate quality systems with external partners and ensure compliance with GMP and FDA standards Provide oversight and leadership to a team of Quality Assurance professionals and drive continuous improvement initiatives Ensure smooth manufacturing operations and compliance at the external manufacturing site, including review of batch documentation Required Qualifications: Bachelor's degree in pharmacy, pharmaceutical sciences, chemistry, or biology is required Minimum of 8 years of experience in a regulated environment, preferably in pharmaceutical, medical device, or biotech quality settings Experience in external manufacturing, technology transfers, and quality system development Demonstrated ability to manage a team and provide cGMP compliance support Position requires living near the FDBN site