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GID Site Manager F/H

CEVA · Louverné, Mayenne, FR

External listingFull-timeabout 1 month ago

About The Role

Define and obtain management approval for the business cases for new product and LCM industrialization, including financial and regulatory aspects, in order to anticipate industrial resource and investment needs. Define the strategy for transferring processes to production and the process validation strategy in compliance with GMPs. Organize monthly industrialization meetings with the industrial teams to provide visibility on new products and LCM/support activities. Define the budget for studies, operating expenses, and capital expenditures, as well as resource allocation and priorities. Assess and escalate project-related risks, liaising with various departments: R D, Regulatory Affairs, Procurement, Franchise, and Management Control. Promote and lead the QbD design and experimental phases. Ensure the day-to-day implementation of QbD through the definition of QTPP, CPP/CQA, and FMECA. Develop synergy between the Laval and Loudéac teams by pooling efforts and technical expertise in analytics/processes (HPLC, PAT, NIR, Raman, etc.) and methodology (DoE, statistical analysis, Minitab, capability, etc.). Ensure the management of GID laboratories (HSE, teams, etc.) and prepare for future initiatives: open lab, pilot unit.

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