mRNA Senior Specialist - External Quality Assurance - ...

In the race for the future of health- The Sanofi mRNA Center of Excellence (CoE) At Sanofi, we believe in a world in which no one suffers or dies from vaccine-preventable diseases. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines for more people faster than before. That''s why we''re looking for bold, optimistic world-changers to join the team at our mRNA Center of Excellence. We''re investing €400m a year into the new Center, hiring a team of 400 dedicated employees for it and using it as the foundation to implement integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams. Bring your ambition and optimism for the future to Sanofi. Join us ABOUT THE OPPORTUNITY The Quality Assurance Senior Specialist reports to the Manager, External Quality Assurance and is an integral part of the Quality team. This position offers opportunities to focus on disposition of product for Sanofi CoE, inclusive of review and release of manufacturing/test documentation from process development, manufacturing and nonclinical, clinical and commercial processes and supply chains. This includes batch records, deviations, CAPAs, CoAs, CoCs, etc. Key responsibilities for position Reviews and approves master production records for the timely initiation of GMP manufacturing activities. Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials SME for Quality in vendor meetings for raw materials, excipients, cell banks and plasmids Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations. Ensure that all requirements, as stipulated in the appropriate QTA, have been met. Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur. Write and revise SOP, forms, WI, and any other document types Assist with internal and external audits. Lead compiling data analysis and metrics for QMR, KPIs, and other reportable forums may be requested. Assume additional responsibilities as assigned. ABOUT YOU Qualifications/ Education & work experience Bachelor''s degree and/or 10+ years of relevant experience; Masters preferred Minimum 8 years of experience in Quality Assurance Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment. Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants. Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines. Preferred experience with outsourced manufacturing and testing operations Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project. 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. As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. According to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. GD-SP LI-SP mRNA PDN At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.

Created: 2025-10-04