Manager GMP Compliance and Inspections

Job description

The Manager GMP Compliance & Inspections will work with cross-functional teams to drive activities that will ensure a state of continuous GMP compliance in Regeneron. This individual will play a leading role in the preparation and execution of regulatory inspections, partner audits and internal audits, as well as follow up post audit/inspection on any items requiring response and action. This role will also promote and drive compliance by building inspection readiness processes across the organization. As the Manager GMP Compliance & Inspections a typical day might include the following: Ensuring readiness for regulatory inspections and partner /other audits in the creation, maintenance and management of inspection content, ensuring it is organized, current and readily accessible at all times P lanning all inspection and audit logistics and scenarios : communication plan, room allocations, backroom/ frontroom configuration, technology checks & personnel assignments Performing a lead role in the audit/inspection Backroom and r esponding to incoming requests during inspections and audits and ensuring timely and accurate responses Evaluating outcomes of regulatory authority inspection...