Senior Manager, Inspection Management

Builds and maintains strong relationships with R&D stakeholders to support compliant execution of inspection activities.,Maintains in-depth knowledge of governmental regulations affecting GCP, GVP, GLP in drug development.,Plans and coordinates GCP, GVP, GLP, GCLP regulatory authority inspections (routine, directed, or submission driven) and the pre-inspection request process.,Coordinates and manages inspection readiness and preparation activities, including trainings, mock interviews, mock inspections, site risk assessments, and clinical site inspection preparation visits.,Provides guidance in developing responses to observations from R&D program inspections.,Ensures critical and major inspection findings have appropriate Corrective and Preventative Actions (CAPA), tracked to completion and verification of effectiveness.,Leads and manages post-inspection lesson's learned sessions, tracking all actions.,Contributes to and maintains inspection management plans, trainings, and strategies for the R&D Quality inspection management program.,Reviews and provides input into study team inspection preparation activities and storyboards.,Collaborates with industry through benchmarking regulatory activities.,Contributes to the R&D Quality Regulatory Intelligence Program, including monthly briefing reports.,Provides input into the issue management program for early detection, robust CAPA development, tracking, and effectiveness assessment.,Supports RDQ&C projects and initiatives.,Provides mentoring for new and junior staff members.,Contributes to the continuing development of a quality culture at Moderna.

BS/BA, MS or PhD with a minimum of 10, 8, or 6 years’ experience respectively, in Biotech, Pharma or Clinical Research Organization.,Knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international GxP regulations, guidelines and local legislation.,Knowledge of relevant FDA, EU, guidance for computerized systems is a plus.,Experience with inspection coordination and logistical planning for regulatory authority inspections.,Experience with work in the Regulatory Intelligence area.,Experience developing responses to regulatory authority inspection findings.,Experience working with CROs, vendors, and relationship management.

Bachelor's Degree (minimum), Master's Degree, or PhD

Travel of up to 30% required.,Position may involve access to U.S. export-controlled technology/data; employment contingent upon ability to access such information in accordance with U.S. law.,Only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible.,Moderna is unable to sponsor non-U.S. persons for an export control license for this role.