Lead Root Cause Analysis for cross-functional issues and any critical risk/issue via dedicated Root Cause Investigator
Coordinates cross-functional CAPA management and advise on CAPA effectiveness checks
Oversee the CAPA closure and effectiveness implementation
Develop training material and train business on risk management (process, methodology, tool), root cause investigations and SMART CAPAs
Contribute to the development, continuous improvement and successful implementation of a simplified and effective process, Management System
Work with the relevant stakeholders to improve our understanding of the challenges and associated solutions to ensure excellence in issue management
Act as first line of support to assist business areas navigate and discharge responsibilities relating to the process as well as address concerns or questions
Partner with Clinical Development Quality Assurance and business partners to create and operationalise robust issue management process that support the organisation in fostering hight quality culture
Use key performance indicators to monitor performance of adoption and implementation of the process
Facilitate the management review and oversight by proactively monitoring signals and business performance