**Job Title:** Quality Assurance L2-1 **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. 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. \#GD-SG ​ \#LI-GZ \#LI-Onsite \#vhd **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. 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)