P2622 - Audit & CAPA Lead

Debiopharm; Lausanne; Vor Ort; CHF 100.000 - 130.000; Vollzeit

Benefits dieser Stelle

Inclusive and respectful workplace

Opportunity for collaboration across disciplines

Culture valuing people, purpose, and performance

Zusammenfassung

Debiopharm in Lausanne, Switzerland is looking for an Audit & CAPA Lead to manage an effective audit framework and quality oversight. Responsibilities include strategic audit management, vendor oversight, and leading continuous improvement initiatives across GxP.

Ideal candidates have extensive experience in quality assurance within the pharmaceutical industry and demonstrated ability to conduct GxP audits. This role fosters a collaborative environment that values innovation and growth in healthcare.

Qualifikationen

• 5 to 8 years managing quality assurance in the pharmaceutical/biotech industry.
• Minimum 5 years conducting GxP audits, preferably GCP & GLP.
• 3 years tracking CAPAs, deviations, changes, with electronic quality tools experience.

Aufgaben

• Define and execute the risk-based audit strategy and Master Audit Plan.
• Select and manage auditors for compliance with regulatory standards.
• Develop meaningful metrics for Audit/CAPA oversight.

Kenntnisse

Knowledge of GxP

Experience implementing risk-based approaches

Ability to maintain quality SOPs

Strong organizational and communication skills

Hands-on approach to continuous improvement

Ausbildung

Pharmacist Diploma, PhD, or MSc in Science

Tools

Veeva

Ennov

Jobbeschreibung

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 across all GxP activities.

Key Responsibilities

• 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.

Requirements

Education & Experience

• 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.

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; 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.

Benefits

• 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.