P2622 - Audit & CAPA Lead

Mission

As the Audit & CAPA Lead, you will ensure an effective, pragmatic, and risk-based Audit & CAPA framework r focus will be on strengthening quality oversight, supporting inspection readiness, and driving continuous improvement across all GxP activities.

• 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).
• Vendor & Auditor Oversight:
  Capitalize on our outsourced audit model by selecting and managing qualified auditors 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 raise critical issues and focus assurance where it matters most.
• Inspection Readiness & CAPA:
  Contribute directly to 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.

• University Degree:
  Pharmacist Diploma, PhD, or MSc in Science (or equivalent).
• Industry
  
  Experience:
  
  5 to 8 years managing quality assurance within the pharmaceutical and/or biotech industry; hybrid experience in both large and small/medium structures is a real asset.
• Audit Expertise:
  Minimum 5 years conducting GxP audits, with a strong preference for GCP & GLP environments.
• Systems
  
  Experience:
  
  Minimum 3 years tracking CAPAs, deviations, and changes (for GCP: CROs, TMF, Investigational Sites, and CSR). Direct experience with validated electronic quality tools (Veeva, Ennov) and knowledge of computerized system validation is highly desirable.
• Recent inspection experience with official regulatory authorities (FDA, EMA, Swissmedics) is a strong asset.

• Solid, comprehensive knowledge of GxP and practical familiarity with risk-based approaches like ICH Q9.
• Proven experience implementing risk-based approaches in alignment with current ICH E6(R3) and ICH E8(R1) regulatory frameworks.
• Proven ability to maintain quality SOPs and translate business priorities/risk signals into a pragmatic, inspection-ready program.
• A strategic thinker who can maintain an overarching global view while bringing rigor and efficiency to daily, detailed activities; an agile communicator strongly exposed to matrix organizations and cross‑functional collaborations.
• High degrees of organization, flexibility, and a hands‑on, pragmatic mindset focused on continuous improvement.

• Being part of a company where innovation, collaboration, and impact are how we work every day.
• Partner with teams across disciplines at the forefront of oncology and anti‑infective development.
• An inclusive and respectful workplace – proud to be Equal‑Pay certified.
• Grow in a culture that values people, purpose, and performance.
• A chance to grow, share, and shape the future of healthcare.