Senior Manager, Inspection Management

About the role

This role focuses on Regulatory Health Authority inspection planning, logistics, and supporting inspections, ensuring compliance with Health Authority Regulations (e.g., FDA, EMA, etc.). Responsibilities include conducting pre-inspection, during inspection, and post-inspection activities across R&D, supporting regulatory intelligence activities, and helping to create a quality culture within Moderna.

Responsibilities

• 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.
• Coverage of 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.
• 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.
• Support RDQ&C projects and initiatives, as assigned.
• Mentors for new and junior staff members, as assigned.
• Contribute to the continuing development of a quality culture at Moderna.

Requirements

• (Basic Qualifications) BS/BA, MS or PhD and a minimum of 10, 8, 6 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.

Qualifications

• (Preferred Qualifications) 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.

Benefits

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs. 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.

Pay & Benefits

The salary range for this role is $130,800.00 - $209,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.

Equal Opportunities

We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.