DirecciónLocation : Barcelona or Madrid (Hybrid)
You will be joining a team of 40 highly talented CQA professionals who are based in various countries across the globe!
As our Associate Director, Development Unit CQA (Clinical QA) Program Lead, you will provide strategic Quality oversight on the entire Clinical Trial Process (CTP) for the clinical trials under responsibility in order to ensure compliance with the Health Authorities requirements, the internal standards and a full adherence to Patients' safety, rights and well-being.
This role reports to the Global Head, Development Unit CQA Programs.
Your responsibilities will include, but are not limited to :
Proactively provide strong QA leadership to the business strategy for assigned trials by ensuring considerable organization awareness (e.
g. Interrelationship of departments and business priorities)
- Support implementation of the quality strategy within GCT under responsibility.
- Regularly monitor the implementation of the annual Quality Plan pertaining to the Clinical chapter and ensure that all delayed activities have a documented rational and appropriate escalation.
- Ensure adequate oversight of proactive quality risk management process in the overseen areas including quality risk assessments and submission / inspection readiness activities and ensure that CTP processes are in control
- Provide robust and clear quality oversight in various areas of clinical development.
- Actively leverage audit / inspection outcomes / trends to sustain improvement in clinical trials conduct.
- Support continuous improvement initiatives (including Work streams) and ensure that areas identified as weaknesses are properly being addressed and executed for sustainability
- Be QA point of contact for the defined trials and attend the meetings and ensure quality is embedded in the decision taking processes.
