* Expertise in GxP-regulated environments, particularly in biopharma and medical device IT Quality & Validation.
* Experience supporting R&D, 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.