Quality Assurance Associate III

Job Description

Responsibilities:

• 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 Quality Third Party and requires the ability to gown and enter manufacturing

Remarks 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.

Must have:

• Must have bachelor’s degree + 6 years of applicable experience
• Manager is open to all levels of experience Experience communicating with 3rd parties, understanding of 3rd party relations with impact QMS, quality agreements.
• Vendor pass, quality agreements, supplier change notification

Nice to have:

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