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.
Your job, as Principal Compliance Specialist on our Quality Assurance (QA) Operations team will be to have quality oversight of operations at Sanofi's Framingham Biologics facilities.
The Principal Compliance Specialist is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP. The Principal Compliance Specialist may also be responsible for providing leadership to the QA team in the absence of the manager.
QA's main responsibility is to ensure cGMPs are adhered to during manufacturing operations. Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality and efficacy of Sanofi's Products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company's business and global markets.
Main Responsibilities
Function as shift lead including developing junior employees; function as department lead for internal audits and back-up for QA Manager.
Provide Gemba Support and perform batch record review.
Review and approve CRs related to EBRs (as applicable)
Function as SME on challenges related to production requiring a quality input
Non-conforming material discard
Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps
Issue action notices and conduct affiliated provisional release
Perform logbook review and conduct logbook audits against compliance requirements; provide off-hour support for batch record and logbook issuance.
Support cross-functional internal audit activities and conduct walkthrough inspections
Function as CAPA owner
Provide expertise during procedure/SOP revision process and function as DCR approver for department related SOPs and PRs
Initiate and investigate and QA review deviations
Represent for QA Ops for various projects (e.g. CCR FMEA, Risk Assessment, RCA).
About You
Master's Degree in scientific field and 4 years of experience and/or bachelor's degree in scientific field and 6 years of experience and/or associate's degree in scientific field and 8 years of experience and/or a High School Diploma and 10 years of experience in a Quality and /or other CGMP related field.
Prior experience in Manufacturing/CGMP environment required.
Minimum 4+ years' experience with a focus in Quality Assurance desired.
Working experience in external agency regulatory audits and knowledge in external agency regulations (FDA, EMA, etc.) strongly preferred.
Demonstrated experience guiding others through Quality Systems such as Deviations, CAPAs, Investigations.
Prior experience leading cross functional teams or projects.
Experience in quality systems/QMS.
Ability to gown and gain entry to manufacturing areas
Ability to work a 10-hour rotating shift 4 days per week, plus every other weekend, including some holidays
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.
