The role of Senior Manager, Inspection Management at Moderna involves regulatory health authority inspection planning, logistics, and supporting inspections, ensuring compliance with health authority regulations and 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.
Requirements
- BS/BA, MS or PhD and a minimum of 10, 8, 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.
- 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.
Benefits
- Best-in-class healthcare coverage
- Voluntary benefit programs
- Fertility, adoption, and surrogacy support
- Generous paid time off
- Savings and investment opportunities
- Location-specific perks and extras
