Senior Manager, Inspection Management

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.). You 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.

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.
• 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 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.
• Provides guidance and direction in the development of responses to observations resulting from inspections of Moderna’s R&D programs.
• Ensures any critical and major inspection findings have appropriate Corrective and Preventative Actions (CAPA) and are tracked to completion and verification of effectiveness.
• Leads and manages 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.
• Reviews and provides 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.
• Contributes to the ongoing operations of the R&D Quality Regulatory Intelligence Program in issuance of multi-discipline monthly briefing reports to the organization.
• Provides 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.
• Supports RDQ&C projects and initiatives, as assigned.
• Provides mentoring for new and junior staff members, as assigned.
• Contributes to the continuing development of a quality culture at Moderna.

Requirements

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

Skills

• 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.

Schedule

Travel of up to 30% required.

Pay

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. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

Benefits

• Competitive healthcare, 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 investments to help you plan for the future.
• Location-specific perks and extras.

About the role

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. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship.