CMO Quality Manager

Description

• Act as the Quality representative in internal core teams (Supply Chain, KAM, Finance, Global Quality) and in joint meetings with CMOs.
• Manage quality events from CMOs, reviewing investigation reports to ensure proper assessment of criticality, root cause, impact, and CAPA effectiveness.
• Evaluate and confirm the CMO's decisions regarding the final batch disposition on behalf of Sanofi.
• Manage internal quality events and related quality alerts, including those triggered by OOS results in IPC/FP testing, stability studies, or others defined by Sanofi QMS.
• Review and assess Change Controls as a quality expert, participating in CC committees and ensuring timely implementation and closure.
• Review, update, and maintain Quality Agreements with CMOs and business partners, ensuring compliance for all delegated Manufacturing & Supply activities.
• Support CMOs during regulatory inspections when required.
• Ensure timely update of CMO‑related information within Sanofi’s Quality Management System.
• Serve as a Subject Matter Expert (SME) and active member of the Quality Community of Practice—implementing standardised processes, supporting end users, and acting as the “voice of the customer” to drive simplification and harmonisation.

Qualifications

• Minimum 5 years of experience in a cGxP or other regulated environment for biotechnology or aseptic pharmaceutical products, ideally in an on-site Quality or Production.
• Strong understanding of pharmaceutical regulations, GxP requirements, and application across the product lifecycle from material supply through to market entry.
• Excellent problem‑solving skills with demonstrated capability in root‑cause analysis and corrective/preventive action implementation.
• Ability to make independent decisions, exercising sound judgment and autonomy.
• Strong communication and collaboration skills when working with both internal teams and external partners.
• Fluency in written and spoken English required; additional languages (especially French) are an asset.