Dr. Anna Rotarska-Jagiela

Dr. Anna Rotarska-Jagiela has extensive experience in computer systems validation and quality assurance within the pharmaceutical sector, currently serving as Senior Director of CSV and IT Quality Assurance at Fresenius Kabi since January 2011, with prior roles including Director and Senior Manager in the same field. Responsibilities have included oversight of computer system validation in GMP environments, adhering to regulations such as 21 CFR Part 11 and GMP Annex 11, as well as managing quality assurance related to GCP, GLP, and pharmacovigilance. Earlier roles included a focus on clinical drug safety and documentation at organizations like the Max Planck Institute for Brain Research and the Psychiatry and Psychotherapy Hospital of Cologne University. Dr. Rotarska-Jagiela holds a Dr. rer. med. in Theoretical Medicine from Goethe University Frankfurt and advanced degrees in psychology from DePaul University and Loyola University Chicago.