P2622 - Audit & CAPA Lead

The Role: 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 for all our clinical trials programs across all GxP activities, and GCP/GcLP in particular. 

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). 
• Perform Internal Audit : on clinical trials, programs or Debiopharm internal processes (mainly in GCP area).

• Vendor & Auditor Oversight: Selecting and managing qualified outsourced auditors (when appropriate) to ensure timely execution and compliance with regulatory standards. 

• Risk-Based Quality Assurance: Embed ICH Q9 concepts and quality