Computer Systems Validation Lead - EMEA

Job description

Job Description The Regional CSV Lead is responsible for establishing and maintaining the framework for Computer Systems Validation (CSV) within the region, ensuring compliance with global and local regulatory requirements (e.g., GxP, FDA 21 CFR Part 11, EU Annex 11). The role will lead and support major validation projects; including enterprise‑level systems such as ERP platforms, while embedding CSV principles into the regional quality management system. Main Responsibilities: Validation Strategy: - Support the design, implementation and maintenance of a regional CSV Quality Management System (QMS) aligned with global standards and corporate policies. - Develop validation policies, procedures, templates, and training materials. - Plan and manage large‑scale validation projects (e.g., ERP, LIMS, eQMS, and other GxP‑relevant systems). Validation Documentation and Risk Assessments: - Develop, review and execute validation protocols, plans, and reports to ensure accuracy, completeness, and compliance with regulatory expectations. - Conduct risk assessments for validation activities and develop mitigation plans to address potential issues. - Review change controls for validated system...