Your missionProvide Quality Assurance oversight and guidance for GxP computerized systems, ensuring compliance throughout their lifecycle—from implementation and validation projects to day-to-day operations.You will serve as a key point of contact forComputerized Systems Validation (CSV)and act as the interface between IT and business teams on eCompliance matters, promoting a culture of quality.Your key responsibilities:Review and approve GxP applicability assessments and key validation deliverables.Review and approve GxP-impacting changes and deviations, ensuring appropriate CAPAs are implemented.Review and approve Periodic Review Reports and ensure identified gaps are addressed through the CAPA management system.Contribute to the preparation and execution of the Validation Master Plan (VMP).Participate in GxP supplier qualification activities and provide Quality support for audits and resulting actions.Advise project and operations teams on CSV and compliance requirements.Support the implementation,



operation and optimization of automation and AI-enabled solutions for eCompliance activities.What we’re looking for:A degree in Information Technology, Life Sciences, Pharmacy, Engineering or an equivalent field.At least 5 years of overall professional experience, with additional experience preferred, including a minimum of4 years of relevant pharmaceutical industry experiencein regulated functions such as IT Quality & Compliance.A strong understanding ofCSV, GxP and 21 CFR Part 11, as well as Health Authority expectations.Experience in the implementation, lifecycle management and day-to-day operation of GxP computerized systems and their supporting technologies.Professional fluency in English, enabling you to work independently, contribute to meetings, review technical documentation and coordinate with international teams.We’d also value:Knowledge of ITIL/ITSM and experience with systems supporting pharmaceutical development, manufacturing, quality, commercial operati

📌 Senior Ecompliance Specialist (Madrid)
🏢 Motum Technologies
📍 Madrid