Senior Manager, Inspection Management

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.

• 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 inspections, site risk assessments and clinical site inspection preparation visits in preparation for regulatory authority inspections.
• Provide guidance and direction in development of responses to observations resulting from inspections of Moderna’s R&D programs.
• Ensure any critical and major inspection findings have appropriate Corrective and Preventative Actions (CAPA) and are tracked to completion and verification of effectiveness.
• Lead and manage post-inspection lessons learned sessions, ensuring all actions are tracked to completion.
• Contributes to and maintains inspection management plans, trainings, and strategies for the R&D Quality inspection management program.
• Review and provide input into study team inspection preparation activities, storyboards, etc.
• Collaborates with industry through benchmarking of regulatory activities that may influence regulatory inspection activities and strategies.
• Contribute to the ongoing operations of the R&D Quality Regulatory Intelligence Program in issuance of multi-discipline monthly briefing reports to the organization.
• Provide input into the issue management program to ensure early detection of issues, development of appropriate and robust corrective and preventative actions (CAPA), tracking of CAPA completion, and assessment of effectiveness is attained.
• Support RDQ&C projects and initiatives, as assigned.
• Provides mentoring for new and junior staff members, as assigned.
• Contribute to the continuing development of a quality culture at Moderna.

• BS/BA, MS or PhD and 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.
• Leadership skills with ability to effectively organize and execute tasks.
• Ability to interact effectively with all levels within the organization.
• Ability to work both independently and in a team environment.
• Strong analytical, problem solving and decision-making skills in a complex, fast-paced, and changing environment.
• Strong communication and presentation skills, both verbal and written.
• Ability to solve complex problems taking a broad perspective to identify innovative solutions.
• Ability to manage multiple projects in a fast-paced environment.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Ability to influence and negotiate effective solutions, excellent interpersonal skills.
• A desire to make an impact as part of a high-growth, transformational company…