
Manufacturing and Supply
Where the
miracles of
science are made
a reality for patients
QA Principal Compliance Specialist, Operations
At a glance
Our teams produce and deliver over 4 billion units of medicines and vaccines every year, ensuring every breakthrough gets to the people who need it most.
Our state-of-the-art facilities, AI-powered smart factories, and cutting-edge automation are redefining what’s possible: ensuring treatments reach patients faster, safer, and more sustainably than ever before. This is where your skills, ambition, and passion can shape the future of healthcare.
Job Title: QA Principal Compliance Specialist, Operations
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.
Join our Quality Assurance (QA) Operations team at Sanofi’s Framingham Biologics facilities! We ensure cGMP compliance during manufacturing to guarantee the safety, quality, and efficacy of our products.
As the QA Principal Compliance Specialist, you’ll provide quality support and direction to Manufacturing, Quality Control, and support functions. You will be responsible for quality on the floor oversight of manufacturing and laboratory operations, complete batch record and analytical data review, and non-significant deviation review to ensure compliance with cGMPs.
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:
Collaboration: Work closely with manufacturing, facilities, engineering, and Quality Control departments. Function as SME on challenges related to production requiring quality input. May train junior employees
Compliance: Review batch records, cleaning logs, environmental monitoring documentation, column packing records.
GEMBA Support: Provide on-the-floor support, issue action notices, and participate in Material Review Board preparation.
Audits: Represent QA during internal and external audits, addressing questions related to QA systems and product disposition.
Deviation Management: Approve deviation investigations, CAPA and GEMBA problem solving.
Decision Making: Challenges include responsible for high complexity decision making related to Quality or Compliance and ensuring that risks or deviation from decisions made by the Quality representative are escalated to QA Operations Management, QA Director or the Quality Site Head as needed to ensure Safety, Identity, Strength, Purity, Quality (SISPQ) of product.
About You
Qualifications:
Basic: Masters with 7+ years, Bachelor’s with 9+ years, Associate’s with 11+ years, or High School Diploma with 13+ years in Quality/cGMP. Experience in Quality Engineering/Assurance/Control and knowledge of cGXP regulations and biologics or similar manufacturing processes.
Preferred: Self-motivated, organized, excellent communicator, detail-oriented, strong interpersonal and project management skills, and proficient in electronic document systems such as Trackwise and/or Veeva, Excel, Word, PowerPoint, and databases.
Special Working Conditions: Ability to gown and enter clean rooms is a requirement for this role.
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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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.
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Why work with us
- We’re problem-solvers and pioneers. United by the belief that everyone deserves a healthier future. We create best-in-class vaccines that prevent disease and protect lives.
- Innovation drives us. From AI and mRNA to next-gen science, we push the boundaries to deliver first- and best-in-class vaccines for infectious diseases worldwide.
- Growth happens here. With bold investments in R&D and world-class facilities, Sanofians across the entire vaccine lifecycle are shaping the future of global health.
- We do what’s right. Sustainability and DE&I drive our positive global impact—because the diverse communities Sanofians represent are the patients we serve.
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"Manufacturing and Supply is the bridge between the science that happens in research laboratories and the people and communities we serve."

Brendan O’Callaghan
Executive Vice President of Manufacturing and Supply
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