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".
* Internal Advisory: Act as an expert advisor on CSV regulations, supporting AI projects from a regulatory/validation standpoint and mentoring staff on CSLC activities.
* Leadership & Quality: Manage, mentor and develop the CSV team, ensuring high‑quality delivery across all portfolio initiatives, identify areas for process improvement, change management and assist with audit planning / CAPA formulation.
Your Profile:
* Education: Minimum of a Master’s degree in Science, Engineering, or a Clinical discipline.
* Experience: Over 10 years in Quality Management within the pharmaceutical industry, with at least 5 years specifically dedicated to CSV and qualification.
* Technical Expertise: Strong working knowledge of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, and ICH GCP E6.
* Innovation & AI: Experience in risk‑based analysis and validation for the implementation of innovative AI solutions is a strong asset.
* Auditing: Proven experience in managing and conducting audits.
* Leadership Style: A strategic thinker who applies a risk‑based approach and can balance high‑level oversight with daily operational efficiency.
* Team Management: Proven track record in leading and developing high‑performing teams of CSV professionals in fast‑paced environments.
* Soft Skills: Deliverables‑driven, pragmatic, and able to thrive in a dynamic, fast‑paced, matrix environment.
* Languages: Fluent in English; fluency in any other European language an asset.
What we Offer:
* Being part of a company where innovation, collaboration, and impact aren’t just values — they’re 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
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