About The Job
Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S; Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S; teams by acting as a crucial link between our R&D; and Manufacturing facilities,
playing a vital role in securing the present portfolio and delivering future launches of high-quality and cutting-edge drugs and vaccines.
This position manages a portfolio of Contract Manufacturing Organizations and Suppliers ensuring comprehensive quality oversight, including management of Drug Products and Drug Substances (APIs). The Expert ensures compliance with GxP, approved product dossiers, local regulations, and Sanofi requirements, serving as a quality focal point for manufacturing, testing, and release activities.
Main Responsibilities
- Quality Focal Point & Oversight: Serve as quality contact for assigned CMO/Supplier portfolio, monitor and evaluate quality KPIs, lead annual quality evaluations, prepare quality presentations for Business Reviews and coordinate inspection support.
- Quality Event & Risk Management: Manage quality events from receipt to closure ensuring proper investigat