Senior Quality Engineer, QMS

Job Title:


Senior Quality Engineer, QMS
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 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 key user of the 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.
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 compliance expertise on the floor.
Ensure compliance with corporate requirements within the QMS
Provide regular metrics, trend reports, and system health assessments.
Lead and mentor peers and contribute to continuous improvement initiatives.
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 6 years in cGMP, or Master's with 4+ 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.
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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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 and check out our Diversity Equity and Inclusion !
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.