P2613 - CSV Lead — Debiopharm
CHF 79'500 - 120'500
Debiopharm · Lausanne (VD)
- Location
- Lausanne
- Contract
- other
- Posted
- 45 days ago
SalaryCHF 79'500 - 120'500
Role overview
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.
- 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.
- 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.
Main 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.
Additional details
- 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.
Notes and original content
- Responsibilities
