P2622 - Audit & CAPA Lead

The Audit & CAPA Lead role at Debiopharm is charged with building and maintaining a pragmatic, risk‑based audit and corrective‑action framework that supports quality oversight, inspection readiness, and continuous improvement across all clinical‑trial programmes, especially within GCP and GcLP activities. Day‑to‑day you will shape the audit strategy together with GxP Quality Leads and business partners, act as the global owner of the audit and CAPA process, and manage the Master Audit Plan that spans third‑party providers, systems, studies and documentation. Your work includes performing internal audits of clinical trials and internal processes, selecting and supervising external auditors, embedding ICH Q9 risk‑management throughout the audit‑CAPA lifecycle, and using trend analysis and key quality indicators to focus assurance efforts. You will also lead preparation for regulatory inspections, collaborate on timely CAPAs, generate audit‑related metrics for senior leaders, and conduct targeted audits on behalf of the company. Candidates must hold a university qualification such