Senior Manager, Regulatory Compliance
3 weeks ago
We are seeking a highly skilled Senior Manager, Inspection Management, R&D Quality to join our team at Moderna. In this role, you will be responsible for leading the planning, coordination, and execution of regulatory health authority inspections across R&D. You will work closely with cross-functional teams to ensure compliance with health authority regulations and develop strategies to maintain a state of inspection readiness.
Key Responsibilities- Build and maintain strong relationships with key stakeholders within R&D to support the successful execution of 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 and the pre-inspection request process.
- Coordinate and manage inspection preparation activities, including inspection management trainings, mock inspection interviews, mock inspections, site risk assessments, and clinical site inspection preparation visits.
- Provide guidance and direction in developing responses to observations resulting from inspections of Moderna's R&D programs.
- Ensure 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.
- Support RDQ 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.
- 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.
- Strong communication and presentation skills, both verbal and written.
- 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 work both independently and in a team environment.
- Strong analytical, problem-solving, and decision-making skills in a complex, fast-paced, and changing 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 of up to 30% required.
Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to develop vaccines and therapeutics. We are committed to making a positive impact on society and are dedicated to creating a culture of belonging and inclusion. We offer a comprehensive and innovative suite of benefits to our employees, including highly competitive medical, dental, and vision coverage options, flexible spending accounts, and lifestyle spending accounts.
We are proud to be an equal opportunity workplace and 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.
We are committed to making a difference in the lives of our employees and the communities we serve. If you are passionate about making a difference and want to join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
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