CSVLead

### _**Together, we innovate, we impact, we grow !**_ _**At Debiopharm, every step we take is guided by one purpose: improving the lives of people affected by cancer and infectious diseases. As a privately-owned Swiss biopharmaceutical company, we’re driven by science, but above all, by the people behind every treatment — the patients and their families.**_ _**Through our unique “development only” model, we bring forward promising therapies and transform them into treatments that can reach those who need them most, faster.**_ We are currently looking for a strategic and hands-on Expert to join our Quality Management team in **Lausanne, Switzerland**. In this high-impact role, you will drive Computerized System Validation (CSV) activities to support our ambitious digitalization initiatives, ensuring our systems remain compliant, efficient, and ready for the future, as a ### **CSV Lead** **Permanent role | Lausanne, Switzerland** ### _**Your Mission:**_ Your mission is to lead and optimize the CSV strategy for Debiopharm International SA (DPI). You will bridge the gap between innovation and compliance, ensuring that our digital evolution is supported by a pragmatic, risk-based validation framework that protects data integrity and patient safety across our portfolio. ### _**Your Key Responsibilities**_ · **Strategy & Oversight:** Evaluate, design, and implement the CSV strategy for both current and new systems, ensuring it is accurately reflected in procedural documents. · **Vendor & Project Integration:** Contribute to vendor selection and qualification, providing pro-active quality oversight for GxP critical systems and processes. · **Execution & Validation:** Direct the CSV approach for project teams, supervising the creation and approval of deliverables, test defects, and risk mitigation activities. · **Lifecycle Management:** Oversee the computerized system portfolio, managing change controls, periodic reviews, and maintenance activities after "Business Go-live".