Quality Assurance Associate III (contract)

Overview

Sanofi's contingent workforce program, FLEXT Direct, is seeking a Quality Assurance Associate III – Third Party Management Specialist for a 5-month contract opportunity.

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 managing Supplier Change Notification (SCN) processes, overseeing third-party quality event investigations, supporting quality agreement programs, and collaborating cross-functionally with QC, Facilities, and Manufacturing teams to resolve compliance issues.

This position reports to the Head of Quality Third Party and requires the ability to gown and enter manufacturing environments.

Key Responsibilities

• Oversee Third Party Quality operations to maintain compliance and quality standards.

• Lead and manage Supplier Change Notification (SCN) processes.

• Manage and investigate third-party quality events and supplier-related issues.

• Support quality agreement programs, including periodic reviews and documentation.

• Communicate and collaborate with external vendors and suppliers to resolve material compliance issues.

• Work cross-functionally with Quality Control, Facilities, and Manufacturing teams.

• Manage investigations related to material defects and single-use systems.

• Communicate supplier changes and coordinate notifications when suppliers modify materials or processes.

• Ensure supplier activities meet global pharmaceutical regulatory requirements.

Basic Qualifications (Required)

• Bachelor’s Degree with 6+ years of applicable experience.

• Experience working in Quality or Operations within a biotech/pharmaceutical cGMP manufacturing environment.

• Experience working in an FDA-regulated industry.

• Experience communicating with third-party vendors and suppliers.

• Understanding of third-party relationships impacting QMS.

• Experience with:

  • Quality Agreements

  • Supplier Change Notifications

  • Vendor Pass / Supplier Compliance

• Strong understanding of global pharmaceutical regulations (US, EU, Canada, Japan, Australia).

• Ability to gown and enter manufacturing environments.

Preferred Qualifications (Nice to Have)

• Experience with Veeva Quality Management Systems

• Experience with Quality Agreements

• Experience in Supplier Compliance

• Experience with Supplier Change Notifications

• Experience using SAP

Additional Notes

• Role will work closely with smaller vendors and external suppliers.

• This is not a post-market compliance role; it focuses on material compliance and supplier quality investigations.