Aequor Technologies
Shift: 1st Work Schedule: Mon-Fri 800-430
The Third Party Management Specialist will oversee Third Party Quality operations for the MA BioCampus, ensuring excellence in quality standards and regulatory compliance across external partnerships. This role requires leading Supplier Change Notification (SCN) processes, managing third party quality event investigations, supporting quality agreement programs including periodic reviews and documentation, and collaborating cross-functionally with QC, Facilities, and Manufacturing departments to resolve compliance issues. The ideal candidate will have a Bachelor's degree or equivalent experience in Supplier Quality, minimum 6 years of Quality/Operations experience in a biotech/pharmaceutical cGMP manufacturing environment within an FDA-regulated industry, proficiency in Veeva quality management systems, and strong knowledge of global pharmaceutical regulations (US, EU, Canada, Japan, Australia). This position reports to the Head of Supplier Governance and requires the ability to gown and enter manufacturing/warehouse areas.
Must have Bachelor's degree + 6 years of applicable experience Must have: Should be an expert in working with suppliers and vendors on material compliance, including single-use systems, material defects, and supplier investigations. Pharma, biotech, GMP manufacturing, or FDA-regulated environment a must
Nice to have: ā¢ Previous experience with Veeva, quality agreements, supplier compliance, supplier change notifications preferred
The Third Party Management Specialist will oversee Third Party Quality operations for the MA BioCampus, ensuring excellence in quality standards and regulatory compliance across external partnerships. This role requires leading Supplier Change Notification (SCN) processes, managing third party quality event investigations, supporting quality agreement programs including periodic reviews and documentation, and collaborating cross-functionally with QC, Facilities, and Manufacturing departments to resolve compliance issues. The ideal candidate will have a Bachelor's degree or equivalent experience in Supplier Quality, minimum 6 years of Quality/Operations experience in a biotech/pharmaceutical cGMP manufacturing environment within an FDA-regulated industry, proficiency in Veeva quality management systems, and strong knowledge of global pharmaceutical regulations (US, EU, Canada, Japan, Australia). This position reports to the Head of Supplier Governance and requires the ability to gown and enter manufacturing/warehouse areas.
Must have Bachelor's degree + 6 years of applicable experience Must have: Should be an expert in working with suppliers and vendors on material compliance, including single-use systems, material defects, and supplier investigations. Pharma, biotech, GMP manufacturing, or FDA-regulated environment a must
Nice to have: ā¢ Previous experience with Veeva, quality agreements, supplier compliance, supplier change notifications preferred