QA Vendor Management Specialist

Job Title: Third Party Management Specialist

Location: Framingham, MA, 01701

Duration: 07 months

Notes:

• Third Party Management Specialist
• Role will work with some of the smaller vendors, will reach out to and workers
• This is not a post-market compliance role, this is on material compliance role – single-use system, defects of materials, they’ll reach out to the supplier to conduct investigations; If suppliers change something, will send out notifications

Must have:

• Must have Bachelor’s degree 6 years of applicable experience
• Manager is open to all levels of experience

Nice to have:

• Previous experience with Veeva, quality agreements, supplier compliance, and supplier change notifications preferred

Job Description

• 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.