Job Description

• In support of the business, manage with maximum efficiency all quality and GMP issues in line with the local business plan and corporate strategy, ensuring highest quality of sanofi products, manufactured locally, to the local market. • Plan and manage all manufacturing process for the products in the local manufacturing plan, in liaison with commercial partners (toll-manufacturer and our Agent) as well as continuous audit of their process. Ensure continuous improvement with suppliers, packaging, work-in-process (WIP), & finished product. • Review the quality agreements with all toll-manufacturers and ensure timely delivery and proper implementation of the agreements (in conformity with sanofi standards) in a fast moving environment. • Develop appropriate management control tools to monitor quality performance of the local suppliers/toll-manufacturers and identify areas of continual improvement, and propose corrective actions where necessary. • Develop & update SOPs and working instructions related to industrial projects. In this regards contribute to the audit of toll-manufacturers in liaison with our Agent. • Manage the development of the Artworks related to the local manufacturing projects, and communicate with medical & marketing departments together with our Agent and toll-manufacturers. Ensure the availability of the materials in due-date and perform all necessary communication with our Agent. • Product labelling compliance, security-label management and keeping the product specification/information up-to-date, in liaison with medial and marketing. • Ensure compliance of the projects with GMP and EMEA standards. This requires monitoring of the production standards and utilization of a production tracking & control system (through participating in the sampling of the products), ensuring the quality of the finished products. • Plan and organize quality assurance and GMP training for key personnel of the toll-manufacturers • Communicate recommendations and changes to the stakeholders to ensure high quality standards of the operational methods, products, documentation are being met. • Provide cross-functional support & effective communication between direct report & with other teams/departments. Manage and optimize professional networks at all levels of the supply chain organization and be proactive in local professional organizations/associations • Report monthly activities