Operations Lead Vaccines

About The Job EM&S Vaccines Operations department is the operational unit responsible for ensuring on‑time and in‑full delivery of products from CMOs (Contract Manufacturing Organizations) and External Partners. The team manages contractual compliance with CMOs and external partners, and ensures all EM&S related functional aspects of tech transfers and commercialization into new CMOs are effective. Position: Operations Lead, Vaccines – Location: Cambridge, MA. Key Responsibilities Manage the implementation of new flows and optimize them. Co‑write new specifications (PTS) under tech transfer leadership and manage changes for specifications in routine mode. Ensure CMOs and MAMPs carry out production according to specifications and contracts. Align production capacity with requirements and contract obligations. Manage production/release flow of subcontractors to meet customer commitments (deadlines/quantities/quality). Follow plan made by Global Supply Chain for Vaccines. Guarantee proper execution of production plans between external partners and Sanofi on partner sites, ensuring on‑time, in‑full delivery within a 0‑6 month horizon. Track production indicators. Coordinate deviations and change controls (timing, release impact, creation of internal quality events) in collaboration with quality teams. Lead execution follow‑up in accordance with planned commitments for all areas supporting external partners (QA, QC, Supply, Logistics, Operations, MSAT, affiliates). Manage purchase orders from procure to payment for Vaccines CMOs in ERP. Escalate key risks and issues to senior management, EMPT and risk manager. Monitor partner performance (KPIs) against production goals, identify and resolve gaps. Participate in quality audits and inspections in collaboration with EM&S LMGMV Quality. Participate in investigations related to customer complaints/CAPA and audits. Contribute to binding offers and project definition as requested by EMPT. Manage tech transfer projects as project manager/leader, or contribute as a project team member. Qualifications Bachelor’s degree in engineering, supply chain management, operations/manufacturing management, or any field with 10+ years of experience. Master’s degree in a related field with 8+ years of experience. Experience in operational roles is required. Good knowledge of DP/DS manufacturing processes. Knowledge of pharmaceutical regulations (US, JP, EUR). Project / program management experience is extremely helpful. Working knowledge within the biotech/pharmaceutical industry is highly preferred. Experience with data analysis, trending, and presenting material within a multi‑functional environment. Demonstrated ability to perform work requiring independent decision making and judgment. Requires ability to travel worldwide up to 20 % of the time. Benefits Supportive, future‑focused team that brings the miracles of science to life. Endless opportunities to grow talent and drive career, including promotions or lateral moves, both domestically and internationally. Thoughtful, well‑crafted rewards package that recognizes contributions and amplifies impact. Health and wellbeing benefits, prevention & wellness programs, and at least 14 weeks of gender‑neutral parental leave. Shape the future of medicine and vaccine delivery with cutting‑edge technology, ensuring seamless launches and a resilient global supply. Leverage digital, data, and AI‑driven innovation – at speed and scale. Transform lives worldwide by delivering life‑changing treatments anywhere, anytime. EEO and Affidavit Statement 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, domestic violence victim status, atypical cellular or blood trait, genetic information (including refusal to submit to testing) or any other characteristic protected by law. #J-18808-Ljbffr Sanofi