Expertise in GxP-regulated environments, particularly in biopharma and medical device IT Quality Validation.Experience supporting RD, Manufacturing, Enterprise Systems, and Medical Devices.Familiarity with modern validation approaches, including Computer Software Assurance (CSA).Strong project and resource management capabilities.A track record of driving process modernization and continuous improvement.Knowledge of medical device regulations, including ISO 13485, FDA 21 CFR Part 820, and EU MDR.Proficiency in risk-based approaches to validation and compliance.Strong analytical and problem-solving skills.