P2613 CSV Lead

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 were 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.

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 Masters degree in Science Engineering or a Clinical discipline.

Experience: Over 10 yearsin 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 arent just values theyre 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

What to Expect in the Recruitment Process:

If your application is selected youll be invited to interviews with Talent Acquisition and the Hiring Manager via Teams followed by a panel interview and reference checks. Communication is handled via Workablecheck your spam folder for emails from *@.

Please contact our HR Department prior to submitting any profiles. We cannot accept unsolicited applications from agencies or recruiters.