Senior Manager, Inspection Management Job at Moderna (Cambridge)

Job Responsibility

Build and maintain strong and productive relationships with key stakeholders within R&D to support the successful and compliant execution of Moderna regulatory inspection activities.
Maintain 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 lesson’s learned sessions, ensuring all actions are tracked to completion.
Contribute to and maintain 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.
Collaborate 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.

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.
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 that is Bold, Relentless, Curious, and Collaborative.

Nice to have

Knowledge of relevant FDA, EU, guidance for computerized systems is a plus.
Experience with work in the Regulatory Intelligence area.
Experience developing responses to regulatory authority inspection findings.
Experience working with CROs, vendors, and relationship management.

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras

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Senior Manager, Inspection Management

Job Responsibility

Requirements

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