In this role, you will lead and supervise the Clinical Quality team within a global biopharmaceutical organisation focused on rare, debilitating and life-threatening diseases. Your GCP and GVP experience ensure you to be in a constant state of inspection readiness. Additionally, you will ensure the compliance of the clinical studies according to the organisation its SOPs and other global regulations. Furthermore, you will focus on leading the team and ensure training & further qualifications; reviewing and approving all clinical and PV QMS documents; collaborating with other departments to ensure GxP compliance; resolving problems and investigating deviations/complaints/non-conformities/CAPAs/etc.; perform internal/external audits and eTMF audits; participate in projects as CQA SME.