Audit & CAPA Lead

About the role

The Audit & CAPA Lead will establish and maintain a risk‑based audit and corrective‑action framework for Debiopharm’s clinical trial programs, ensuring inspection readiness and continuous quality improvement across GxP activities.

Key responsibilities

• Define and execute a risk‑based audit strategy in partnership with GxP Quality Leads and business partners, maintaining the Master Audit Plan.
• Conduct internal audits focused on GCP, oversee third‑party auditors, and manage vendor auditor selection.
• Lead preparation for regulatory authority inspections (FDA, EMA, MHRA) and drive timely, effective CAPA implementation.
• Develop and report audit/CAPA metrics to senior leadership and champion global continuous‑improvement initiatives.

Required profile

• University degree in pharmacy, science (PhD, MSc, or BSc) or equivalent.
• 5‑8 years of quality‑assurance experience in pharma/biotech, with at least 5 years conducting GCP audits.
• Recent experience leading GCP inspection preparations for regulatory agencies.
• Minimum 3 years managing CAPA, deviations, and change tracking in GCP environments.

Required skills

• Strong knowledge of GxP regulations and risk‑based approaches (ICH Q9, ICH E6(R3), ICH E8(R1)).
• Hands‑on experience with validated electronic quality tools such as Veeva and Ennov.

What we offer

• Opportunity to work at the forefront of oncology and anti‑infective development.
• Inclusive, equal‑pay certified workplace that values collaboration and impact.
• Culture focused on people, purpose, and performance with growth potential.