P2622 - Responsable Audit & CAPA

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 Gx P activities.

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 Gx P 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 elevate 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 Gx P 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.

Your Profile

Education & Experience

• University Degree: Pharmacist Diploma, Ph D, or MSc in Science (or equivalent experience).
• 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 would be a real asset.

• Audit Expertise: Minimum 5 years of experience conducting Gx P audits, with a strong preference for GCP & GLP environments.
• 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.

• Recent inspection experience with official Regulatory Authorities (FDA, EMA, Swissmedics) a strong asset.

Skills & Core Competencies

• Solid, comprehensive knowledge of Gx P 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 with strong exposure to matrix organizations and cross‑functional collaborations.

• High degrees of organization, flexibility, and a hands‑on, pragmatic mindset focused on continuous improvement.

What We Offer

• Being part of a company where innovation, collaboration, and impact aren’t just values - they are how we work everyday.
• 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.
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