mRNA - Senior Specialist, Quality Systems - Vaccine

In the race for the future of health- The Sanofi mRNA Center of Excellence (CoE) At Sanofi, we chase the miracles of science, and we know mRNA has a role to play in the future of health. 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 and treatments for more people faster than before. That''s why we''re looking for bold, optimistic world-changers to join our mRNA Center of Excellence. We''re investing €400m a year into the new Center, hiring a team of 450 dedicated employees, and focusing on implementing an integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams. Bring your ambition and optimism and join us on our journey to discover and deliver transformative medicine to patients through the advancement of our cutting-edge mRNA technology! About the Opportunity The Sr Specialist of Quality Systems supports all cGMP quality systems at Sanofi''s mRNA Center of Excellence (CoE) and its corresponding documentation, reporting into the Quality Systems Manager. The Sr Specialist supports the development and implementation of GxP quality systems, ensuring Sanofi''s mRNA CoE processes and control strategy is in compliance with US and international regulations, laws and guidelines which oversee the manufacturing and testing of investigational clinical trial materials. The Sr Specialist duties include but are not limited to: system administration operations for all Quality Systems and events, developing and issuing Quality Systems reports and management of Sanofi''s mRNA CoE Quality Systems- to include: Corrective and Preventative Action (CAPA), Change Controls, Deviations/Investigations, Quality/Operational Risk Management, Quality Metrics, Internal and External audits, Inspection Readiness and manage Sanofi''s mRNA CoE Risk Management Program. Key responsibilities for position Supports the successful design, implementation and roll out of Sanofi''s mRNA CoE Risk Management program. Develop a compliant and phase appropriate program for Risk Management within Sanofi''s CoE, providing a solid rationale of risk and mitigating it through appropriate and robust controls. Serve as the site Subject Matter Expert in the development and implementation of an effective QRM program, covering activities such as research and development, sourcing of materials, manufacturing, packaging, testing, storage and distribution. Administrates, facilitates and maintains ongoing support of compliant and effective quality systems at Sanofi''s mRNA CoE, including policies and procedures- while keeping them current with emerging and changing regulations. Keeps Quality system trackers and metrics up to date. Implements continuous improvement for electronic quality systems. Interacts with internal and external partners for development of best practices in Sanofi''s mRNA CoE quality systems and procedures. Guide Change Control, CAPA and Deviation owners and partner with cross-functional teams in their assessment of documents- ensuring they are consistently and timely managed, closed, appropriately filed in Sanofi''s mRNA CoE QMS and according to procedure. Supports the management and improvement of Sanofi''s mRNA CoE Inspection Readiness Program. Write, review and approve Standard Operating Procedures (SOP) and Forms for the organization Assist in build-out, management and continuous improvement of the eQMS and SOP system. Creates Internal/External audit calendars, and prepares, organizes and leads audit management activities. Plan audit calendars, develops audit schedules and maintains audit logs. Lead resource in communication with the external vendor, schedule creation and ensures timely project deliverables, acts as key Sanofi mRNA CoE point person in vendor management. Functions as administrator to schedule, plan, execute and document internal audits of Sanofi''s mRNA CoE QMS. Ensures all audit findings are closed in a timely manner with effective corrective action, by assisting owners on investigations and action plans. Leads inspection preparation, resolution management of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audit. Supports the execution of the remediation responses to ensure progress by working with key stakeholder in their timely completion of identified deliverables. Responsible for the organization and maintenance of the Vendor Management Program, which includes the vendor approval and qualification process and maintenance of the Approved Vendor List. Ensures new vendor request forms are created and vendor evaluations are completed. Lead resource in communication with external vendors for creation and response to vendor questionnaires. Writes, reviews and negotiates Quality Agreements with Vendors. Assure consistency in achieving product quality and compliance across multiple CMOs and CROs. Provides the data assembly for quality metrics for GxP related functional areas within the organization. About you Bachelor''s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area Pharmaceutical/biotechnology industry experience (7+ years) with at least 5 years in a Quality function. Technical knowledge in the US (ISO-13485, ISO-14971, etc.) and EU cGMP guidelines (ICH Q7, Q8, Q9, Q10), including Annex 2 and other international regulatory requirements. Demonstrated understanding that QRM is the overall and continuing process of appropriately managing risks to product quality throughout the product''s life-cycle in order to optimize its benefit-risk balance. Well-developed organizational and communication skills. Works well cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements. Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization. Excellent written and verbal communication skills and proficiency in Microsoft software applications including Word, Excel, Visio, PowerPoint, Outlook, and SharePoint. Ability to run small to medium sized quality related projects. Technical knowledge and experience with data analysis, reporting, and trending. Ability and desire to work in a fast-paced, start-up environment. Strong collaboration, team-building skills and communication skills Independently motivated and detail-oriented with good problem-solving ability. Demonstrated effective time management skills. Sound judgment and commitment to ethical conduct. 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 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.

Created: 2025-10-04