Principal Quality Engineer, QMS

Job Title: Principal Quality Engineer, QMS)

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 Operations team at Framingham Biologics facilities! We support CAPAs, Deviations, Change Controls, supplier quality, document control, and more. Our mission is to ensure all Quality Systems activities meet regulations and drive continuous improvements.

As a SME for CAPA, Deviation, and Investigation (CDI) QMS, you’ll oversee system health, be the quality approver for records for this system, identify improvement opportunities, and lead implementations. You’ll also engage in multi-department forums to ensure best practices.

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:

• Collaborate with various departments to review and approve complex Change Control (CCR) and CDI records.

• Represent the Quality System team in policy discussions.

• Attend GEMBA on the production floor to assess deviations, impact, and root cause analysis.

• Provides technical expertise and supports high-level decision making. 

• Ensure compliance with corporate requirements and monitor system access.

• Provide regular metrics, trend reports, and system health assessments.

• Lead and mentor peers, support global initiatives, and drive continuous improvement.

• 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: Bachelors in science/engineering with a minimum of 9 years in cGMP, or Master’s with 6+ years. 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.

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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