Senior Manager, Inspection Management

Job description

The Role In this role, you will primarily focus on Regulatory Health Authority inspection planning, logistics, and supporting inspections, ensuring compliance with Health Authority Regulations (e.g., FDA, EMA, etc.) and will be responsible for conducting Regulatory Authority pre-inspection, during inspection and post-inspection activities across R&D. The appointee will also support regulatory intelligence activities, partner with local R&D functions and study teams to create a quality culture within Moderna and help reach a sustained state of inspection readiness Here's What You’ll Do: Builds and maintains strong and productive relationships with key stakeholders within R&D to support the successful and compliant execution of Moderna regulatory inspection activities. Maintains in-depth knowledge of governmental regulations affecting GCP, GVP, GLP in the drug development process. Plan, and coordinate GCP, GVP, GLP, GCLP regulatory authority inspections (routine, directed or submission driven) and the pre-inspection request process. Coordinate and manage inspection readiness and preparation activities such as inspection management trainings, mock inspection interviews, mock inspectio...