Karen Dimitrijeski is a Digital Quality & Automation Consultant with over 10 years of experience in Quality roles supporting regulated IT across the Medical Device, Pharmaceutical, and Biotechnology industries. She translates complex global regulatory expectations into clear, actionable solutions that position Quality as a strategic partner, not a bottleneck. Her core expertise includes risk-based GxP system validation (CSV/CSA), data integrity, lifecycle management, and audit readiness.

Her background spans Quality System Management, systems administration, and business ownership for global, enterprise-scale regulated applications supporting hundreds of sites and thousands of users. She has partnered closely with infrastructure operations, IT security, data-center qualification teams, ITSM process owners (change, incident, problem, and access management), and SaaS/IaaS suppliers to ensure that enterprise systems remain compliant, resilient, and audit-ready throughout their lifecycle.

Karen builds scalable, system-agnostic automation architectures that modernize regulated software ecosystems, strengthen governance, and accelerate digital transformation—enabling Quality, ITSM, Security, and Infrastructure teams to operate as aligned partners rather than siloed functions.