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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Data Integrity & Computerized Systems Validation Lead Europe - **Company:** Sharp Clinical Services - **Location:** Heerenveen, Netherlands - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Audit Trail, Data Integrity, Information Lifecycle Management, Microsoft Office, System Testing, Iq/oq/pq, Computerised Systems, GXP - **Published:** June 17, 2026 - **Apply:** https://nl.indeed.com/viewjob?jk=a610b960b00579bd ## About the Role Do you have experience in Supervising experience?, Do you have a Master's degree?, * Preferably a Master's or Bachelor's degree in IT, minimum HBO (higher professional education) working and thinking level * Significant experience in GMP-regulated environment * Experience with setting up and supervising CSV or other validation studies is a plus. * Strong experience in Data Integrity and Computerized System Validation (CSV) * Knowledge of GAMP5, EU GMP, Annex 11, Chapter 4, 21 CFR Part 11, ALCOA++ * Experience with validation lifecycle (URS, IQ/OQ/PQ, continued validation) * Experience with quality systems, procedures, training, etc. * Experience with multi-site quality oversight is a plus * Proficient in MS Office * Good knowledge of English and Dutch (written and spoken) * Experience in writing reports * Strong ownership and accountability * Ability to influence without direct authority * Analytical and risk-based thinking * Strong communication and stakeholder management * Strategic and operational balance * Continuous improvement mindset * Able to organize tasks independently and set the right priorities, as well as work in a team. * Willing to travel to Sharp Netherlands, Belgium, and Wales locations for short periods (depending on the location) ## Description Are you passionate about ensuring data integrity and compliance in a highly regulated environment? As Data Integrity & CSV Lead, you will be responsible for safeguarding the integrity, compliance, and validation status of all GxP-relevant data and computerized systems across our sites in the Netherlands, Belgium, and Wales. You will define and maintain the Data Integrity framework and Computerized System Validation (CSV) strategy, ensuring compliance with ALCOA++, EU GMP Annex 11, Chapter 4, 21 CFR Part 11, and GAMP 5 requirements., * Establish and maintain harmonized Data Integrity and CSV frameworks across Europe sites * Own DI and CSV policies, procedures, and standards aligned with global requirements * Maintain oversight of DI and validation status of all GxP computerized systems * Ensure systems remain in a validated state and changes are assessed through CSV and DI lens * Lead and standardize DI and CSV risk assessments (including system and process risks) * Ensure controls across full data lifecycle and system lifecycle (validation lifecycle) * Partner with IT/Engineering to ensure system controls (audit trails, access, backup, interfaces) meet DI requirements * Review and approve validation deliverables (URS, risk assessments, IQ/OQ/PQ, reports) from a DI/CSV perspective * Ensure DI and CSV requirements are embedded in validation, change control, deviations, and CAPA processes * Act as SME during audits/inspections for both Data Integrity and CSV * Drive inspection readiness and remediation of findings related to DI and CSV * Define and deliver training strategy for DI and CSV across Europe sites * Lead continuous improvement and harmonization initiatives across sites * Lead and execute Data Integrity and CSV remediation activities, including gap assessments, root cause analysis, and implementation of corrective and preventive actions across EU sites. * Develop, update, and author DI and CSV deliverables, including risk assessments, procedural updates, validation documentation (URS, protocols, reports), and remediation plans. ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [The Future of Recruiting: Innovations and Challenges in the European IT Sector](https://www.wearedevelopers.com/videos/1056-the-future-of-recruiting-innovations-and-challenges-in-the-european-it-sector) - [Resilient by Design: Building Robust Architectures in High-Stakes Financial Systems](https://www.wearedevelopers.com/videos/2106-resilient-by-design-building-robust-architectures-in-high-stakes-financial-systems) - [Unlocking the potential of Digital & IT at Vodafone](https://www.wearedevelopers.com/videos/602-unlocking-the-potential-of-digital-it-at-vodafone) - [No Keys for the Robot: GitOps as the Control Plane for Autonomous Agents](https://www.wearedevelopers.com/videos/100095-no-keys-for-the-robot-gitops-as-the-control-plane-for-autonomous-agents) - [Rethinking Recruiting: What you didn’t know about Responsible AI](https://www.wearedevelopers.com/videos/1090-rethinking-recruiting-what-you-didn-t-know-about-responsible-ai) ## Related Articles - [Best Companies in the Netherlands: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/193-best-companies-in-the-netherlands-top-25-companies-in-2023) - [The Netherlands – Europe’s powerhouse for software development?](https://www.wearedevelopers.com/magazine/31-the-netherlands-europe-s-powerhouse-for-software-development) - [Software Developer Salary in The Netherlands [2023]](https://www.wearedevelopers.com/magazine/217-software-developer-salary-in-the-netherlands-2023) - [How to land a developer job in Amsterdam](https://www.wearedevelopers.com/magazine/36-how-to-land-a-developer-job-in-amsterdam) - [How to Find Tech Jobs in Amsterdam](https://www.wearedevelopers.com/magazine/279-how-to-find-tech-jobs-in-amsterdam) - [Average Salary in The Netherlands](https://www.wearedevelopers.com/magazine/272-average-salary-in-the-netherlands)