P2622 - Audit & CAPA Lead

pbThe Role: Mission /b /ppAs 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. /ppbKey Responsibilities /b /ppIn 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: /pliStrategic 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). /liliPerform Internal Audit : on clinical trials, programs or Debiopharm internal processes (mainly in GCP area). /liliVendor Auditor Oversight: Selecting and managing qualified outsourced auditors (when appropriate) to ensure timely execution and compliance with regulatory standards. /liliRisk-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. /liliInspection Readiness CAPA: Lead the preparation and conduct of Regulatory Authority Inspections. Partner with GxP Quality Leads to develop timely, impactful CAPAs. /liliMetrics Continuous Improvement: Develop and generate meaningful Audit/CAPA metrics to provide clear oversight for department heads and drive global continuous improvement initiatives. /liliHands-on Auditing: Conduct targeted audits on behalf of Debiopharm International /lipbRequirements /b /ppbYour Profile /b /ppbEducation Experience: /b /pliUniversity Degree: Pharmacist Diploma, PhD, MSc or BSc in Science (or equivalent experience). /liliIndustry 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. /liliAudit Expertise: Minimum 5 years of experience conducting audits and supervising audits in GCP environments (mandatory) and GLP / other GxP audits is a plus. /liliGCP Inspection Experienceb: /b Recent and strong experience in leading preparation of Regulatory Authorities GCP inspections (eg. FDA, EMA, MHRA…) /liliSystems 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 systems validation is highly desirable. /lipbSkills Core Competencies: /b /pliSolid, comprehensive knowledge of GxP and practical familiarity with risk-based approaches like ICH Q9. /liliProven experience implementing risk-based approaches in alignment with current ICH E6(R3) and ICH E8(R1) regulatory frameworks. /liliProven ability to maintain quality SOPs and translate business priorities/risk signals into a pragmatic, inspection-ready program. /liliA 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. /liliHigh degrees of organization, flexibility, and a hands-on, pragmatic mindset focused on continuous improvement. /lipbBenefits /b /ppbWhat we Offer: /b /pliBeing part of a company where innovation, collaboration, and impact aren’t just values — they’re how we work every day /liliPartner with teams across disciplines, at the forefront of oncology and anti-infective development /liliAn inclusive and respectful workplace — proud to be Equal-Pay certified /liliGrow in a culture that values people, purpose, and performance /liliA chance to grow, share, and shape the future of healthcare /lipbWhat to Expect in the Recruitment Process: /b /ppIf 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 . /ppPlease contact our HR Department prior to submitting any profiles. We cannot accept unsolicited applications from agencies or recruiters. /p