Associate Director, Inspection Management

The Role

In this role, you will be a key contributor in the establishment of planning and managing Regulatory Health Authority inspections, ensuring compliance with Health Authority Regulations (e.g., FDA, EMA, etc.) and will be responsible for leading Regulatory Authority pre-inspection, during inspection and post-inspection activities across R&D. The appointee will also contribute to the regulatory intelligence program, applies established knowledge and experience with GCP regulations, guidelines and local legislation to the auditing process to identify compliance issues associated with the conduct of clinical trials.  The appointee will 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.

• Leads, plans, strategizes and coordinates GCP, GVP, GLP 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.

• Perform and lead audits of GCP investigator sites, studies, system and vendor audits.  Work with Moderna clinical staff to ensure the proposed corrective/preventative actions received from the auditees is appropriate and implemented.

• Participate in post-audit meetings to present/discuss audit findings. 

• 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 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 tools, checklists, trainings, and strategies for the R&D Quality inspection management program.

• Review and provide input into study team inspection preparation activities, storyboards, etc.

• 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

• Travel up to 30% required

• Additional duties as may be assigned from time to time

Here’s What You’ll Need (Minimum Qualifications)

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

Here’s What You’ll Bring to the Table (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.

• Strong auditing skills and ability to communicate significant observations to auditees in a sound and factual manner.

• 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