Expertise inGxP-regulated environments, particularly in biopharma and medical device IT Quality Validation.
Experience supportingRD, Manufacturing, Enterprise Systems, and Medical Devices.
Familiarity with modern validation approaches, includingComputer Software Assurance (CSA).
Strongprojectandresource managementcapabilities.
A track record of drivingprocess modernization and continuous improvement.
Knowledge ofmedical device regulations, including ISO 13485, FDA 21 CFR Part 820, and EU MDR.
Proficiency inrisk-based approachesto validation and compliance.
Strong analytical and problem-solving skills.