What are the responsibilities and job description for the Third Party Management Specialist position at Sanofi?
Job title: Third-Party Management Specialist
Location: Framingham, MA
About the Job
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.
The Third-Party Quality team delivers strategic leadership and comprehensive oversight for Third Party Quality compliance across the MA BioCampus. Our focus is on ensuring excellence in quality standards and 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 are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
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
The ideal candidate will have strong analytical skills, excellent communication abilities, and a thorough understanding of quality management systems in the pharmaceutical industry.
Basic Qualifications
A Bachelor’s degree or equivalent work experience in Supplier Quality.
Minimum 6 years Quality and/or Operations experience in a biotech/pharmaceutical cGMP Manufacturing Environment within a FDA regulated 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 gown 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.
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.
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