With 25 years of professional experience in the GMP environment, I have contributed across multiple departments, specializing in Quality Assurance (QA) and Computerized System Validation and Compliance (CSV&C). I am responsible for overseeing computerized systems, ensuring data integrity (across systems, procedures, and user behavior), and managing validation processes and deliverables to ensure compliance with both internal standards and external regulatory requirements. My role involves cross-border collaboration, expert consultation, and publishing as a recognized authority in CSV. Special Skills Pharmaceutical-, Medical- and Cosmetic-Industry, specializing in bioengineering, bioinformatics and compliance, EU-, FDA-Audit readiness, GMP, Data Integrity, Quality Systems, Computerized System Validation along the automation pyramid. LeadershipEstablishment of the department for Computer System Validation, including related activities such as creating job descriptions, training, standards, and other necessary processes. Developing and mentoring junior and senior team members.