Dr. Hermann Lehn

Managerial responsibility for all outsourcing of toxicology studies from F. Hoffmann-La Roche, with the reporting line unchanged (new departmental name was Pharmaceutical Sciences, PS). Responsible for the planning and capacity management group within PS as well as for the GLP archiving activities and for the study submission group. Greater insight in the processes, capabilities and capacities of many CROs around the world, in addition to their compliance status.

Line manager for Roche GLP QA groups in Basel, Nutley, NJ, and Palo Alto, CA. Reporting to Global Head of Nonclinical Safety. Managed 4 GLP inspection by Swissmedic and 4 of US FDA (all positive) Project manager for computerized systems used in GLP studies, decommissioning of more than 20 legacy systems Responsible for the fully GLP compliant closure of the two North American GLP testing facilities Responsible for the conduct of 300 CRO inspections by Roche GLP QA (I reviewed all inspection reports)

Responsible for the GLP QA groups at 2 German and 3 US sites (East and West Coast). During this time, I have successfully managed 5 inspections by German GLP Monitoring Authorities and 3 GLP inspections by US FDA, in Germany as well as in the US. Co-founder of the German QA Society DGGF ("Deutsche Gesellschaft für Gute Forschungspraxis") with about 1,000 members which makes it No. 4 in the world. I have served for more than 10 years in the board of the society.

Ph.D. at German Cancer Research Center, Heidelberg