The Role: Mission
As the Audit & CAPA Lead, you will ensure an effective, pragmatic, and risk-based Audit & CAPA framework at Debiopharm. Your focus will be on strengthening quality oversight, supporting inspection readiness, and driving continuous improvement for all our clinical trials programs across all GxP activities, and GCP/GcLP in particular.
Key Responsibilities
In this role, you will be responsible to define a risk-based audit strategy in close collaboration with key stakeholders, and will act as the global Audit & CAPA process and system owner, serving as the single point of contact to support business representatives. Your core duties will include:
- 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).
- Perform Internal Audit : on clinical trials, programs or Debiopharm internal processes (mainly in GCP area).
- Vendor & Auditor Oversight: Selecting and managing qualified outsourced auditors (when appropriate) 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 escalate critical issues and focus assurance where it matters most.
- Inspection Readiness & CAPA: Lead 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 S.A.
Requirements
Your Profile
Education & Experience:
- University Degree: Pharmacist Diploma, PhD, MSc or BSc in Science (or equivalent experience).
- Industry Experience: At least 5 to 8 years managing quality assurance within the pharmaceutical and/or biotech industry. Hybrid experience in both large and small/medium size structures would be a real asset.
- Audit Expertise: Minimum 5 years of experience conducting audits and supervising audits in GCP environments (mandatory) and GLP / other GxP audits is a plus.
- GCP Inspection Experience: Recent and strong experience in leading preparation of Regulatory Authorities GCP inspections (eg. FDA, EMA, MHRA…)
- Systems Experience: Minimum 3 years tracking CAPAs, deviations, and changes (e.g., for GCP: CROs, TMF, Investigational Sites, and CSR). Direct experience with validated electronic quality tools (e.g., Veeva, Ennov) and knowledge of computerized systems validation is highly desirable.
Skills & Core Competencies:
- 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. Agile communicator being strongly exposed to matrix organizations and cross-functional collaborations.
- High degrees of organization, flexibility, and a hands-on, pragmatic mindset focused on continuous improvement.
Benefits
What we Offer:
- Being part of a company where innovation, collaboration, and impact aren’t just values — they’re 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
What to Expect in the Recruitment Process:
If your application is selected, you’ll be invited to interviews with Talent Acquisition and the Hiring Manager via Teams, followed by a panel interview and reference checks. Communication is handled via Workable—check your spam folder for emails from *@outbound.workable.com.
Please contact our HR Department prior to submitting any profiles. We cannot accept unsolicited applications from agencies or recruiters.
Skills Required
- University degree (Pharmacist Diploma, PhD, or MSc in Science) or equivalent experience
- 5 to 8 years managing quality assurance within pharmaceutical or biotech industry
- Minimum 5 years conducting GxP audits
- Experience in GCP and GLP audit environments
- Minimum 3 years tracking CAPAs, deviations, and changes for GxP activities (e.g., CROs, TMF, investigational sites, CSR)
- Direct experience with validated electronic quality tools (e.g., Veeva, Ennov)
- Knowledge of computerized systems validation
- Recent inspection experience with Regulatory Authorities (FDA, EMA, Swissmedics)
- Comprehensive knowledge of GxP and risk-based approaches such as ICH Q9
- Experience implementing risk-based approaches aligned with ICH E6(R3) and ICH E8(R1)
- Proven ability to maintain quality SOPs and develop inspection-ready programs
- Strong communication, stakeholder management, and ability to work in matrix organizations
What We Do
Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to develop tomorrow's standard of care to cure cancer & infectious diseases and improve patient quality of life.
