Audit & CAPA

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 risk management practices across the entire audit and CAPA lifecycle. Use trend analysis and key quality indicators to escalate critical issues and focus assurance where it matters most. 

• Inspection Readiness & CAPA: Lead the preparation and conduct of Regulatory Authority Inspections. Partner with GxP Quality Leads to develop timely, impactful CAPAs. 

• Metrics & Continuous Improvement: Develop and generate meaningful Audit/CAPA metrics to provide clear oversight for department heads and drive global continuous improvement initiatives. 

• Hands-on Auditing: Conduct targeted audits on behalf of Debiopharm International S.A. 

Requirements

Your Profile 

Education & Experience: 

• University Degree: Pharmacist Diploma, PhD, MSc or BSc in Science (or equivalent experience). 

• Industry Experience: At least 5 to 8 years managing quality assurance within the pharmaceutical and/or biotech industry. Hybrid experience in both large and small/medium size structures would be a real asset. 

• Audit Expertise: Minimum 5 years of experience conducting audits and supervising audits in GCP environments (mandatory) and GLP / other GxP audits is a plus.