Quality Third Party Management Specialist

Job Title: Quality Third Party Management Specialist

• Location: Framingham, MA

About the Job

The Third-Party Quality team delivers strategic leadership and comprehensive oversight for Third Party Quality compliance across the MA Bio Campus. Our focus is on ensuring excellence in quality standardsand regulatory adherence in all external partnerships. The Third-Party Management Specialist is responsible for overseeing Third Party Quality for the MA BioCampus. This role is crucial in maintaining high-quality standards and ensuring compliance in our Relationships with external partners.

About Sanofi:

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Main Responsibilities

Supplier Change Notification (SCN) Management:

• Lead the SCN process

• Provide training on SCN workflow

• Ensure cross-functional approach to SCN completion

• Coordinate subject matter expert involvement

• Maintain system health and timely responses

Third Party Quality Event (TPE) Management:

• Collaborate with Third Parties on investigations

• Ensure cross-functional approach to TPE completion

• Manage returns of investigation materials to third parties

Quality Agreement Program:

• Support Sanofi MA sites and Global quality agreements

• Develop and maintain periodic review schedules

• Assign and oversee quality agreement reviews

• Ensure all quality agreements are approved and properly documented

Compliance and Regulatory Awareness:

• Interpret complex documentation for new and current compliance procedures

• Stay informed on regulatory enforcement trends and actions

Problem-Solving and Collaboration:

• Assist in resolving compliance issues related to third parties

• Work closely and collaborating with Manufacturing, Continuous Improvement, Operational

• Excellence, Quality Assurance, Quality Control, Facilities, and other departments

About You

Basic Qualifications

• Bachelor’s degree in Life Sciences (Biology, Chemistry, Microbiology), Engineering (Chemical, Biomedical, Industrial Pharmaceutical Sciences or related field, or equivalent 5+ work experience in Supplier Quality.

• 3+ years Quality and/or Operations experience in a biotech/pharmaceutical cGMP

• Manufacturing Environment within a FDA regulated industry.

• The ideal candidate will have strong analytical skills, excellent communication abilities, and a thorough understanding of quality management systems in the pharmaceutical industry.

Preferred Qualifications

• Proficient in Veeva quality management system

• Experienced in third-party quality investigations, quality agreements, and supplier change notifications

• Skilled in analyzing complex documentation for regulatory compliance

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

• Excellent communication and presentation skills, with ability to influence senior management

• Experienced in LEAN manufacturing principles and continuous improvement methodologies

• Adept at identifying trends and developing key performance metrics

Special Working Conditions

• Ability to grow and gain entry to manufacturing and warehouse areas

Why choose us?

•  Bring the miracles of science to life alongside a supportive, future-focused team. 

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. 

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale

• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SG

#LI-GZ

#vhd

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.