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, creating and maintaining a Master Audit Plan covering third parties, systems, studies and documents.
• Perform internal GCP audits, oversee outsourced auditors, and lead preparation for regulatory inspections (FDA, EMA, MHRA).
• Embed ICH Q9 risk‑management practices, use trend analysis and quality indicators to focus assurance efforts.
• Develop and report audit/CAPA metrics to drive global continuous‑improvement initiatives.

Required profile

• University degree in pharmacy, science or equivalent (PhD, MSc, BSc).
• 5‑8 years of quality assurance experience in pharma/biotech, with at least 5 years conducting GCP audits and leading inspection preparations.
• Experience tracking CAPAs, deviations and changes, preferably with validated electronic quality tools.

Required skills

• Proficiency with electronic quality systems such as Veeva and Ennov.
• Strong knowledge of GxP regulations, ICH Q9, ICH E6(R3) and ICH E8(R1) frameworks.

What we offer

• Opportunity to work at the forefront of oncology and anti‑infective development.
• Inclusive, equal‑pay certified workplace with a culture that values people, purpose and performance.
• Potential for professional growth and impact on the future of healthcare.