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**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 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

+ Bachelor’s degree with 6+ years in 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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Pursue** **_progress_** **, discover** **_extraordinary_

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

_US and Puerto Rico Residents Only_

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

_North America Applicants Only_

The salary range for this position is:

$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 (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .

Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)