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. Here’s What You’ll Do 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. 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 RDQC projects and initiatives, as assigned. Provide mentoring for new and junior staff members, as assigned. Contribute to the continuing development of a quality culture at Moderna. Here’s What You’ll Need (Basic Qualifications) BS/BA, MS or PhD and a minimum of 10, 8, 6 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization. Here’s What You’ll Bring to the Tabel (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. Travel Requirements Travel of up to 30% required. Pay & Benefits 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. The salary range for this role is $130,800.00 - $209,400.00. 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. Equal Opportunities Moderna is 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. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at View email address on click.appcast.io. 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. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #J-18808-Ljbffr Initial Therapeutics, Inc.