Manager Batch Release US - Vaccine

ROLE RESPONSIBILTIES Quality Review of Batch Records Perform final Quality review of completed manufacturing records for completeness and accuracy according to site procedures, cGMP, FDA''s 21 CFR, and other applicable health authority regulations. Complete all required system transactions associated with the batch record review process. Provide data for PDR manufacturing dates and Commodity Verification Sheets to allow further processing of material. Disposition of Batches Review Specification Checklist, Certificate of Analysis (and Conformance) to verify all required testing has been performed and all testing meets requirements prior to batch disposition. Verify CBER release is received (if applicable) prior to batch disposition. Verify the lot is not on hold (i.e., deviations, change controls, Approve for Further Manufacture database, etc.) prior to batch disposition. Serve as the SME and function as a liaison for any assigned focus factory initiatives and participate in teams, communicating issues and identifying solutions to support release timelines. Contribute to team objectives and priorities on assigned projects Preparation & Certification of Working Documents Prepare batch records from master documents in the electronic the document management system according to procedure Ensure the right first time preparation and completion of required documentation via electronic system (SAP and/or TrackWise) Provide support as required to ensure records are prepared and certified in accordance with the production planning schedule. Certified prepared batch records to ensure completeness and accuracy in accordance with procedure. Provide metrics in support of +QDCI board meetings. Compliance and Performance Act as Trainer for Batch Release activities. Meet department safety, quality, productivity, and cost targets and goals in a compliant and timely manner Act as Trainer for Batch Release activities. Investigate deviations, as assigned. Perform special projects as assigned by PQ Deputy Director. Team member/leader of the assigned project team(s). This includes, but is not limited to, review and approval of the project related requirement documents, IS Change Requests, LabWare MDM forms, protocols, reports, user and functional specifications, etc. Continuously reviews PQBR processes, and recommends, develops, and implements efficiency and quality enhancements EDUCATION REQUIREMENTS: Minimum Bachelor''s degree, preferably in Science or Life Sciences, with at least 3 years in a cGMP controlled/ pharmaceutical industry, preferably in a regulated Quality environment. KEY TECHNICAL COMPETENCIES AND SOFT SKILLS: The position requires intense concentration and visual examination of GMP documents. Excellent analytical, communication, and interpersonal skills, as well as strong organizational and teamwork abilities. Knowledge of cGMP (US, Canada, Japan, Europe). Experience in SAP, Geode+, LIMS, TrackWise, and Phenix is highly preferred. 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. 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-SP LI-SP 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