P2622 - Responsable Audit & CAPA

Mission

As the Audit & CAPA Lead, you will ensure an effective, pragmatic, and risk‑based Audit & CAPA framework at Debiopharm. Your focus will be on strengthening quality oversight, supporting inspection readiness, and driving continuous improvement across all GxP activities.

Key Responsibilities

In this role, you will be responsible to define a risk‑based audit strategy in close collaboration with key stakeholders and will act as the global Audit & CAPA process and system owner, serving as the single point of contact to support business representatives. Your core duties will include:

• Strategic Audit Management: Define the risk‑based audit strategy alongside GxP Quality Leads and Business Partners. Create, maintain, and execute the Master Audit Plan (covering third parties, systems, studies, and documents).
• Vendor & Auditor Oversight: Capitalize on our outsourced audit model by selecting and managing qualified auditors to ensur...