Sanofi US
Job Title:
Quality Third Party Management Specialist Location:
Framingham, MA About the Job
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. 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. About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. 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 collaboratively 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
Bachelor’s degree with 6+ years in Quality and/or Operations experience in a biotech/pharmaceutical cGMP 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. Equal Opportunity
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, marital status, gender identity, sexual orientation, disability, veteran status, domestic violence victim status, atypical cellular or blood trait, genetic information or any other characteristic protected by law. US and Puerto Rico Residents Only North America Applicants Only Salary range: $67,500.00 - $97,500.00. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
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Quality Third Party Management Specialist Location:
Framingham, MA About the Job
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. 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. About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. 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 collaboratively 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
Bachelor’s degree with 6+ years in Quality and/or Operations experience in a biotech/pharmaceutical cGMP 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. Equal Opportunity
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, marital status, gender identity, sexual orientation, disability, veteran status, domestic violence victim status, atypical cellular or blood trait, genetic information or any other characteristic protected by law. US and Puerto Rico Residents Only North America Applicants Only Salary range: $67,500.00 - $97,500.00. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
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