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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