Vertex Pharma
R&D Quality Risk Management
Designed and Implemented R&D Quality Risk Management in alignment with ICH Q6 (R3)
HOW WE HELPED
Developed and implemented a strategic, enterprise-wide approach to QRM within R&D Quality.
Partnered across Quality functions to ensure a holistic, proactive, and integrated approach to risk.
Collaborated with cross-functional teams to assess, mitigate, and govern risks, embedding risk-based thinking into decision-making processes.
Launched the Operational Governance Forum of the R&D QRM. Served as the R&D representative during the implementation of the ServiceNow QRM software.

Performance Monitoring
4 KPI's Implemented
Documentation developed
SOP, WI, Job Aids, Playbook
Operational Governance Structure
Launched and scheduled on a monthly cadence
Community of Practice (CoP)
Network of Risk Champions in # R&D functions
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