Third Party Management Specialist

Description

Internal Title: Third Party Management Specialist

Some slight flex on schedule start/ stop time Fully onsite position/ Free parking onsite

Local candidates only

• Role will work with some of the smaller vendors, will reach out to and worker
• 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 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, supplier change notifications preferred

Duties 

• The Third Party Management Specialist will oversee Third Party Quality operations for the MA Bio Campus, 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.