We are partnering with a general Life Sciences organisation undergoing a number of critical digital and compliance initiatives and are seeking an experiencedValidation Managerto lead validation activities across regulated clinical and quality systems.This is an excellent opportunity for a hands‑on CSV professional who combines strong validation expertise with leadership capabilities and experience operating within highly regulated GxP environments.Key ResponsibilitiesLead validation activities for regulated GxP systems throughout the SDLC.Author and review validation deliverables including URS, risk assessments, test scripts, test execution evidence, validation reports and traceability documentation.Collaborate with business, quality, IT and vendor stakeholders to ensure compliant system implementation and operation.Provide guidance on Computer Systems Validation (CSV), data integrity and regulatory compliance requirements.Support validation activities across clinical,



quality and enterprise platforms.5+ years' experience in Computer Systems Validation within Life SciencesStrong validation experience across clinical and quality systems, including:Clinical Systems (CTMS, EDC, IRT advantageous)Experience validating or implementing Learning Management Systems (LMS), ideally:SumTotalCornerstoneSuccessFactors LMSSimilar regulated LMS platformsExperience with Identity & Access Management systems, including:OKTAIdentity Service CloudSSO / Access Management platformsStrong understanding of:GAMP 5Annex 1121 CFR Part 11Data Integrity principlesHands‑on experience creating and reviewing:URSFunctional RequirementsTest ScriptsValidation DocumentationTest ReportsPrevious leadership, team lead or line management experienceBusiness Analysis skillsProcess mapping and data flow analysisGlobal pharmaceutical, biotechnology or CRO environments#J-18808-Ljbffr

📌 Validation Manager (Madrid)
🏢 Planet Pharma
📍 Madrid