Audit & CAPA Lead

About the role

The Audit & CAPA Lead will shape and operate a risk‑based audit and corrective‑action framework for Debiopharm, ensuring robust quality oversight across all GxP activities. You will partner with GxP Quality Leads and business units to drive inspection readiness and continuous improvement.

Key responsibilities

• Define and maintain a risk‑based audit strategy and Master Audit Plan covering third‑party, system, study and document audits.
• Select, manage and oversee outsourced auditors to ensure timely, compliant execution.
• Embed ICH Q9 risk‑management concepts throughout the audit and CAPA lifecycle, using trend analysis and key quality indicators.
• Support preparation for regulatory authority inspections and lead the development of effective CAPAs.
• Generate and report audit/CAPA metrics to senior leadership and champion global continuous‑improvement initiatives.
• Conduct targeted audits on behalf of Debiopharm International S.A.

Required profile

• University degree in pharmacy, science (PhD or MSc) or equivalent experience.
• 5–8 years of quality‑assurance experience in the pharmaceutical/biotech sector, with exposure to both large and mid‑size organizations.
• Minimum 5 years of GxP audit experience, preferably in GCP and GLP environments.
• At least 3 years of experience tracking CAPAs, deviations and changes, including work with CROs, TMF and investigational sites.
• Recent experience with FDA, EMA or Swissmedic inspections is a strong asset.

Required skills

• ICH Q9, ICH E6(R3) and ICH E8(R1) frameworks.
• GCP and GLP audit methodologies.
• Validated electronic quality tools such as Veeva and Ennov.
• Computerized systems validation knowledge.