Validation CSV Expert GDIT R&D and Medical
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Job Summary
Title:
Validation CSV Expert GDIT R&D and MedicalCompany:
Ipsen Pharma (SAS)About Ipsen:
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!
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Job Description:
Ipsen is strengthening its R&D and Medical Digital & IT organization to ensure the highest standards of compliance quality and audit readiness across its digital ecosystem.
We are looking for a Computer System Validation (CSV) Manager to act as the quality gatekeeper for IT systems supporting R&D this role you will ensure that all computerized systems are fully compliant with regulatory requirements and internal quality standards while enabling innovation and efficient delivery of digital solutions.
You will work at the intersection of IT Quality Regulatory and business teams ensuring that systems are validated audit-ready and aligned with global compliance frameworks.
Your key responsibilities
- Define and lead the CSV strategy for R&D IT systems ensuring compliance with global regulations (GxP FDA etc.).
- Act as the guarantor of system validation and compliance ensuring all systems are audit-ready at all times.
- Oversee the full validation lifecycle (URS FS/DS IQ/OQ/PQ documentation periodic reviews).
- Ensure high-quality validation documentation aligned with regulatory expectations and internal standards.
- Lead audit and inspection readiness acting as a key contact for internal and external audits.
- Support IT and project teams in embedding validation requirements into system implementations and changes.
- Manage change control processes and assess validation impacts across system evolutions.
- Collaborate closely with IT QA Regulatory Quality and business stakeholders to ensure alignment and compliance.
Your profile & expertise
- 68 years of experience in Computer System Validation (CSV) within the pharmaceutical or life sciences industry.
- Strong knowledge of regulatory frameworks (GxP FDA 21 CFR Part 11 Annex 11 GAMP5).
- Solid experience managing the validation lifecycle and audit/inspection processes.
- Experience working with R&D systems (e.g. Veeva LIMS ELN).
- Ability to combine strategic vision with hands-on execution.
- Strong stakeholder management skills in cross-functional and regulated environments.
- High level of rigor in documentation and compliance practices.
- Ability to communicate with regulatory authorities and audit teams.
- Strong influencing and transversal leadership skills.
- Fluent in English.
Why join Ipsen
- A critical and high-impact role ensuring compliance of R&D digital systems.
- Strong exposure to regulatory quality and IT environments.
- A strategic position at the core of innovation and compliance balance.
- A collaborative and international environment focused on patient impact and excellence.
Key Skills
About Company
Ipsen is a global biopharmaceutical company focused on innovation and specialty care to improve the lives of patients around the world.
