Audit & CAPA Lead Consultant (6-Month Contract)

About the role

Debiopharm is looking for an Audit & CAPA Lead Consultant for a 6-month contract in Lausanne. You will strengthen quality oversight, support inspection readiness and drive continuous improvement for its clinical trials programmes across GxP activities, especially GCP/GcLP. You will act as the global Audit & CAPA process and system owner and single point of contact for business representatives.

Key responsibilities

• Define a risk-based audit strategy with GxP Quality Leads and Business Partners, and create, maintain and run the Master Audit Plan covering third parties, systems, studies and documents
• Perform internal audits of clinical trials, programmes and internal processes, mainly in GCP
• Select and manage outsourced auditors when appropriate
• Embed ICH Q9 quality risk management across the audit and CAPA lifecycle, using trend analysis and quality indicators to escalate critical issues
• Lead preparation and conduct of regulatory authority inspections and partner with Quality Leads on timely CAPAs
• Develop Audit/CAPA metrics and drive continuous improvement
• Carry out targeted audits on behalf of Debiopharm International S.A.

Required profile

• University degree: Pharmacist diploma, PhD, MSc or BSc in science (or equivalent experience)
• 5 to 8 years managing quality assurance in pharma/biotech; hybrid experience in large and smaller structures is an asset
• Minimum 5 years auditing and supervising audits in GCP environments; recent experience leading GCP inspection preparation (FDA, EMA, MHRA etc.) is required
• Minimum 3 years tracking CAPAs, deviations and changes (CROs, TMF, sites, CSRs); experience with validated electronic quality tools such as Veeva or Ennov is highly desirable

Required skills

• Solid knowledge of GxP and risk-based approaches such as ICH Q9
• Experience implementing risk-based approaches under ICH E6(R3) and ICH E8(R1)
• Maintaining quality SOPs and building an inspection-ready programme
• Agile communication in matrix organisations and cross-functional teams

The recruitment process involves interviews with Talent Acquisition and the Hiring Manager, a panel interview and reference checks. Unsolicited applications from agencies or recruiters are not accepted.