Director, Inspection Management, R&D Quality

The Role

In this role, you will play a crucial role in Moderna's inspection management program.  Your primary focus will be to coordinate and oversee Regulatory Health Authority inspections, upholding adherence to Health Authority Regulations such as those set by the FDA, EMA, and other Agencies. You will lead the charge in all phases of Regulatory Authority inspections within R&D, including pre-inspection preparation, on-site inspection management, and post-inspection follow-up. Additionally, you will be an active participant in our regulatory intelligence program.  In this position you will partner with R&D to create a quality culture within Moderna and help reach a sustained state of inspection readiness. 

Here's What You’ll Do:

• Leads the development of quality and compliance strategies for support of global health authority GCP, GVP, GLP, GCLP inspection activities.

• 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.

• Leads, plans, strategizes and coordinates GCP, GVP, GLP, GCLP regulatory authority inspections (routine, directed or submission driven) and the pre-inspection request process.

• Leads, manages and implements the strategy of inspection preparation activities such as inspection management trainings, mock inspection interviews, mock inspections, and site risk assessments 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.

• Collaborates with industry through benchmarking of regulatory activities that may influence regulatory inspection activities and strategies.

• 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.

• Develop and maintain inspection management resources such as tools, checklists, trainings, and strategies for the R&D Quality inspection management program.

• Review and provide consultation on study team inspection preparation activities, storyboards, etc.

• 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 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

Here’s What You’ll Bring to the Table:

• BS/BA, MS or PhD and a minimum of 15, 10, 8 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.

Preferred Qualifications (qualifications particular to the role)

• 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 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 desir