Senior Manager, Inspection Management

Role Summary

Senior Manager, Inspection Management responsible for Regulatory Health Authority inspection planning, logistics, and supporting inspections across R&D, ensuring compliance with Health Authority Regulations. The role includes conducting pre-, during-, and post-inspection activities, supporting regulatory intelligence, and promoting a quality culture to reach inspection readiness.

Responsibilities

• Builds and maintains strong relationships with key stakeholders within R&D to support compliant 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 (routine, directed, or submission driven) and the pre-inspection process.
• Coordinate and manage inspection readiness activities such as trainings, mock inspections, risk assessments, and site preparation visits.
• Provide guidance in developing responses to observations from inspections of Moderna‚Äôs R&D programs.
• Ensure critical and major inspection findings have CAPAs tracked to completion and verify effectiveness.
• Lead post-inspection lessons learned sessions and track actions to completion.
• Contribute to inspection management plans, trainings, and strategies for the R&D Quality inspection management program.
• Review study team inspection preparation activities and materials.
• Collaborate with industry to benchmark regulatory activities influencing inspection strategies.
• Support ongoing Regulatory Intelligence program activities and issue management to enable early detection and robust CAPA.
• Support RDQ&C projects and initiatives; provide mentoring for new/junior staff.
• Contribute to developing a quality culture at Moderna.

Qualifications

• Required: BS/BA, MS, or PhD with a minimum of 6‚Äì10 years in Biotech, Pharma, or CRO (level depending on degree).

Skills

• Knowledge of FDA, EU, ICH GCP guidelines and international GxP regulations; familiarity with computerized systems is a plus.
• Experience with inspection coordination and regulatory intelligence.
• Experience developing responses to regulatory inspection findings; experience with CROs/vendors and relationship management.
• Leadership, strong communication and presentation skills; ability to work independently and in teams.
• Strong analytical, problem-solving, and decision-making abilities in a fast-paced environment.
• Ability to manage multiple projects and collaborate in a cross-functional matrix environment; strong interpersonal skills.

Education

• BS/BA, MS, or PhD in a relevant field; advanced degrees preferred depending on level of experience.

Additional Requirements

• Travel up to 30% may be required.