Moderna
Audit Management Process Across the GxP Landscape — Risk Management & Process Optimization
Optimized Moderna’s GxP audit management by conducting risk-based gap analysis and launching a global SOP-driven program that improved oversight, training, and mitigation controls.
HOW WE HELPED
- Led a full gap assessment of the Quality Management Audit process across GxP areas
- Collected Voice of the Customer (VoC) to surface key audit gaps
- Performed pFMEA to prioritize risks using RPN scoring
- Developed SOPs and audit program policies to address findings
- Enabled global implementation across US and EU sites through training and coordination
- Established KPIs to monitor performance and risk mitigation
- Strengthened controls and reduced audit-related risk severity in the future-state process
Regions Covered
US & EU
Risk Tool Used
pFMEA
Audit Gaps Addressed
High-priority
SOPs Developed
Program-wide
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