Senior Manager Quality, EM&S Gen Med North America Employer Sanofi Location Framingham, Massachusetts Start date Sep 9, 2026 View more categories View less categories Discipline Quality , Quality Control Required Education Associate Degree Position Type Full time Hotbed Genetown Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details Job title :

Senior Manager Quality, EM&S Gen Med North America Location:

Framingham, MA About the Job This role reports to the Senior Director, Quality, EM&S Gen Med NA and is part of a team that has primary responsibility for providing quality oversight for 3rd party subcontractors such as CMOs, suppliers, and contract labs, to oversee activities of QA/QC and compliance functions to ensure compliance with current Good Manufacturing Practices (cGMPs) and Quality Management System (QMS). This position interacts extensively with North American manufacturing/packaging sites, contract manufacturers, and with sites inside and outside the U.S. which manufacture products that include all dosage forms for numerous global markets. The individual works closely with the contractors, quality team, supply chain, MSAT, regulatory, and other appropriate groups to ensure compliance and continuous improvement in quality functions to ensure compliance with cGMPs and regulatory submissions. Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi:

Were an R D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives. About You Basic Qualifications Bachelor's degree in a Science field. 3+ years of experience in Pharmaceutical Operations or Quality Operations with the application of cGMPs in the Pharmaceutical or related regulated industry. Open to domestic and international travel (25-30% of time). Co-op or internship experience will be considered.

Preferred Qualifications:

Excellent oral and written communication skills in cGMP documentation. Experience in third party manufacturing Quality and Regulatory function and/or same plat experience. Interpersonal skills to interface with suppliers and customers to develop privileged communications and relationships. Excellent teamwork and negotiation skills in dealing with internal and external partners with the ability to lead and manage quality related projects. Effectively communicate at all levels of associates in the Sanofi organization (from operator to vice president) or supplier and customer at all levels. The incumbent should possess significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical and medical device industries, especially those related to handling product complaints and the associated regulations. Thorough knowledge of GMP's and regulatory requirements. Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, lyophilized and medical drug/device combinations. Project management skills. Knowledge of French to effectively interface with headquarters.

Main responsibilities:

Ensures the Quality and Regulatory compliance of products subcontracted to external entities on behalf of Sanofi in accordance with cGMPs and Sanofi Quality directives. Ensures the efficiency of Quality System implemented between Sanofi and the sub-contractors ensuring relevant management for complaints, deviations, change controls, non-conformities, or any activity aiming to ensure the production, the control, and the release/disposition of products accordingly with Quality, regulatory, and procedural requirements. Strengthens the Quality and Regulatory strategy particularly during crisis management and verify the implementation of the relevant action plans. Support the External Manufacturing North America Audit program by working with and conducting contractor audits to assure compliance with Sanofi Quality Directives, current Good Manufacturing Practices (cGMPs), and regulatory filings. Leads or participates in the subcontractors audits and managers the CAPAs that follow. Supports and manage projects assigned such as new product launch, onboarding/offboarding or subcontractors and products. Identify and assist in the resolution of quality related issues that impact cGMP compliance, regulatory filing, or other risks to Sanofi products. Develops and negotiates the subcontractors Quality Agreements defining the responsibilities between both parties and provides quality advice to subcontractors. Participates with subcontractors to find solutions concerning quality issues. Respond to customer complaints, including close out and determination of corrective actions. Identify and prevent or resolve issues that could impact the continuity of supply of existing products. Review/Approve sub-contractor's validation protocols, Master Documents and significant deviations and investigations. Regular and frequent contact with vendors through formal meetings (systematic business review meetings) or informally when issues cannot wait. Constant contact with the Senior Director of Quality and Regulatory, EM- North America and Global Quality. Regular contact with Legal to ensure compliance with the activity to all laws and in preparation of Quality Agreements. Collaborate with numerous countries affiliates. Decision making for quality and compliance issues including but not limited to the disposition of changes, deviations qualifications/validation approval of investigations and assist in the decisions to inform regulatory agencies on issued. Escalate non-routine matters to management. Solve problems by working with quality and technical counterparts at external manufacturing sites as well as the technical/analytical team internally. 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 its 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. Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply. Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride. Develop new skills, explore cross-functional roles, and work in an environment that values growth and discovery. #GD-SA #LI-SA #vhd #LI-Hybrid 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. Company Pursue Progress. Discover Extraordinary. Science has been our calling from the beginning. Sanofi's heritage of turning the impossible into the possible stretches back to the 19th century — a rich history of healthcare innovation built by diverse companies united by one shared purpose. More than 150 years later, that spirit lives in everything we do and every person we serve — from the patients who take our medicines, to the healthcare professionals who trust us, to the 83,000+ employees and communities around the world who make it all possible. And today, we're writing the next chapter of that legacy. We are an R D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Better is out there. Better medications, better outcomes, better science. And it all starts with people like you — from different backgrounds, in different locations, doing different roles — united by a single mission: we chase the miracles of science to improve people's lives. Take the most important step in your career and help us change the lives of patients, families, and communities for the better. Company info Location Cambridge Massachusetts United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Quality Assurance Specialist, On the floor (Overnights) East Greenbush, New York Advisor/Sr. Advisor - Technical Services/Manufacturing Science Richmond, Virginia