Risk

• Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.
• As part of the upstream protocol authoring process, partner with Drug Development, to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.
• During trial conduct, provide feedback on risks to study specific critical to quality factors and ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun.
• Conduct quality assurance spot checks to ensure risk mitigation strategies are accurately translated into operational plans.
• Provide regulatory intelligence on current and upcoming regulations to ensure we remain compliant with all applicable requirements.
• Partner with the study teams to ensure effective management of significant quality issues/noncompliance and important protocol deviations for CtQ data, processes and vendors.
• Support the monitoring and evaluation of CtQ factors throughout the study lifecycle and adapt Quality plans accordingly.
• Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements.

Associate Director, Quality Risk Specialist

Senior Business Control Specialist – QC Risk Governance

Senior Governance Engineer

Senior Director of Risk

Director, Asset Management Risk

Senior Program Portfolio Manager – Enterprise Transformation, Governance Frameworks