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.
• 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.
• Assist the business in defining and establishing Acceptable Ranges/QTL and KRIs for CtQ data.
• Provide regulatory intelligence on current and upcoming regulations to ensure we remain compliant with all applicable requirements.
• Establish strong partnerships with business stakeholders.
• Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline.
• Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to the business and Health Authorities, as needed.

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