P2622 - Audit & CAPA Lead

Debiopharm seeks a Senior Audit & CAPA Lead in Lausanne to oversee global audit strategies, CAPA processes, and inspection readiness within GxP environments.

The company is looking for a senior professional to establish and maintain a pragmatic, risk-driven audit and corrective action framework. This role focuses on enhancing quality oversight, ensuring readiness for regulatory inspections, and fostering ongoing improvement across all GxP operations.

Responsibilities

• Collaborate with key stakeholders to design a risk-focused audit strategy.
• Serve as the global owner of the audit and CAPA process and systems, acting as the primary support contact for business teams.
• Develop, update, and implement the Master Audit Plan, which includes audits of third parties, systems, studies, and documentation.
• Identify and oversee qualified auditors to guarantee timely execution and adherence to regulatory standards.
• Integrate ICH Q9 principles and quality risk management throughout the audit and CAPA lifecycle.
• Assist in preparing for and conducting inspections by regulatory authorities.
• Work alongside GxP Quality Leads to create effective and timely corrective actions.
• Generate and analyze audit and CAPA metrics to provide oversight for department heads and support global improvement efforts.
• Perform targeted audits on behalf of Debiopharm International S.A.

Requirements

• Hold a university degree in pharmacy, science, or a related field, or possess equivalent professional experience.
• Have 5 to 8 years of experience managing quality assurance in the pharmaceutical or biotech sector.
• Possess at least 5 years of experience conducting GxP audits, preferably within GCP and GLP settings.
• Demonstrate a minimum of 3 years tracking CAPAs, deviations, and changes, particularly in GCP contexts such as CROs, TMFs, investigational sites, and clinical study reports.
• Experience with validated electronic quality tools like Veeva or Ennov is highly desirable, along with knowledge of computerized systems validation.
• Maintain comprehensive knowledge of GxP regulations and practical familiarity with risk-based approaches such as ICH Q9.
• Show proven experience implementing risk-based approaches aligned with ICH E6(R3) and ICH E8(R1) frameworks.
• Demonstrate the ability to maintain quality SOPs and translate business priorities into a pragmatic, inspection-ready program.

Nice to have

• Experience working in both large and small to medium-sized organizations.
• Recent experience with regulatory authority inspections, such as those by the FDA, EMA, or Swissmedics.

What the company offers

• Join a company where innovation, collaboration, and impact are central to daily operations.
• Collaborate with cross-disciplinary teams at the forefront of oncology and anti-infective development.
• Work in an inclusive and respectful environment, with the company holding Equal-Pay certification.
• Grow within a culture that prioritizes people, purpose, and performance.
• Contribute to shaping the future of healthcare through professional development and shared knowledge.

About the company

Debiopharm operates at the forefront of oncology and anti-infective development, fostering a workplace culture built on innovation, collaboration, and impact. The company is committed to an inclusive and respectful environment, recognized by its Equal-Pay certification, and values people, purpose, and performance in all its operations.

• Innovation, collaboration, and impact are core values that guide daily work.
• The company is at the forefront of oncology and anti-infective development.
• The workplace is inclusive and respectful, with Equal-Pay certification.
• The culture values people, purpose, and performance.