IT Validation Lead – GxP Data Migration

Pharmaceutical / Healthcare industry project involving validation for large-scale GxP data migration from a legacy platform to a new regulated IT solution.

• Strong experience in IT Validation within pharma or another regulated industry, with the ability to lead validation activities independently
• Hands-on experience with validation of GxP data migrations, including data mapping, transformation, reconciliation, migration testing, and migration reporting
• Experience with validation of system interfaces and integrations, including APIs or other automated data transfers and related control mechanisms
• Experience with GxP supplier assessment, including evaluation of supplier capabilities, quality processes, documentation, and validation evidence
• Strong knowledge of GxP, data integrity, risk-based validation, quality processes, and risk identification, with a quality-focused mindset
• Degree in Computer Science, Engineering, Software Development, Life Sciences, or a related field
• Experience with large-scale projects and agile methodologies; familiarity with Azure DevOps, test management, and test automation is advantageous
• Skilled in stakeholder management and communication, ensuring timely involvement of key stakeholders such as LoB, IT QA, Process QA, Business Owners, Architects, IT Security, and suppliers
• Promotes a healthy and collaborative working environment and is comfortable driving tasks, decisions, and follow-up across multiple teams

• Own and drive GxP validation activities for the migration from a legacy system to a new regulated IT solution
• Define and maintain the migration validation approach, including validation plans, risk assessments, test documentation, reports, and traceability
• Support definition and verification of the migration process, including data mapping, transformation rules, reconciliation, completeness and accuracy checks, exception handling, and migration evidence
• Plan, coordinate, and execute migration testing together with business representatives, developers, IT QA, Process QA, and other relevant stakeholders
• Assess and validate interfaces and integrations between regulated IT systems, including data transfer controls, error handling, reconciliation, and interface testing
• Perform or coordinate GxP supplier assessments and evaluate supplier documentation and controls as input to the validation approach
• Manage validation deviations, defects, risks, and follow-up actions through resolution and documented closure
• Work independently as Validation Lead, take responsibility for validation deliverables and participate as the validation expert in large-scale IT projects in Development