Debiopharm seeks a CSV Lead in Lausanne to oversee and optimize the company’s computerized system validation strategy, ensuring compliance with GxP and regulatory standards while supporting innovation in oncology and anti-infective development.
This role leads the CSV strategy for Debiopharm International SA, aligning digital innovation with regulatory compliance to support the company’s development-focused mission in bringing therapies to patients faster.
Responsibilities
- Assess, design, and roll out the CSV strategy for existing and new systems, ensuring alignment with procedural documentation.
- Support vendor selection and qualification, providing quality oversight for GxP-critical systems and processes.
- Guide project teams on CSV practices, overseeing the creation, approval, and resolution of deliverables, test defects, and risk mitigation steps.
- Manage the computerized system portfolio, including change controls, periodic reviews, and post-go-live maintenance.
- Serve as a regulatory expert on CSV matters, advising on AI projects and mentoring staff on CSLC activities.
- Lead, mentor, and develop the CSV team, promoting quality delivery, identifying process improvements, and supporting audit planning and CAPA development.
Requirements
- A Master’s degree in Science, Engineering, or a Clinical field is required.
- At least 10 years of experience in pharmaceutical Quality Management, including 5 years focused on CSV and system qualification.
- Solid understanding of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, and ICH GCP E6.
- Demonstrated experience in managing and performing audits.
- Proven ability to lead and develop high-performing CSV teams in dynamic environments.
- Fluency in English is required.
Nice to have
- Experience applying risk-based validation approaches to innovative AI solutions.
- Fluency in any other European language.
What the company offers
- An environment where innovation, collaboration, and impact are central to daily work.
- Opportunities to collaborate with cross-disciplinary teams advancing oncology and anti-infective therapies.
- An inclusive and respectful workplace, recognized with Equal-Pay certification.
- A culture that prioritizes people, purpose, and performance.
- A chance to contribute to and shape the future of healthcare.
About the company
Debiopharm is committed to science and the people behind treatments — patients and their families. Operating under a 'development only' model, the company accelerates the delivery of promising therapies. Its culture emphasizes innovation, collaboration, and impact, supported by an inclusive and respectful workplace environment.
- Driven by science and patient-centered care.
- Operates under a 'development only' model to bring therapies to patients faster.
- Values innovation, collaboration, and impact in daily operations.
- Maintains an inclusive and respectful workplace, certified as Equal-Pay compliant.
- Cultivates a culture that values people, purpose, and performance.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.