Quality Third Party Management Specialist

Sanofi•Framingham, MA

15h

About The Position

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. 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.

Requirements

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.

Nice To Haves

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

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

Benefits

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.

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