Kurt Moerck

Background

About Kurt Moerck

I am a GMP Quality and Compliance professional with over 40 years´ experience within the Pharmaceutical, Medical Device and Healthcare Industry, including over 30 years’ Global Experience at 3 of the largest Worldwide Pharmaceutical Companies: Sandoz/Novartis, Sanofi-Aventis and SmithKline Beecham (SB), as well as Alcon Labs. I am a USA citizen having lived and worked for the last 30 years in Europe and am now based in Germany. My leadership experience has involved the creation and effective management of Audit and Compliance programs at SB, Sanofi-Aventis and Sandoz/Novartis across sites in the USA, Europe, LATAM & Asia. I also have extensive experience in the Quality and Compliance aspects of R&D operations, including Clinical Trials Materials, having been responsible for R&D Quality at Rhone Poulenc Rorer/Aventis. Responsibilities have also included Global Senior Advisor and Consultant for Quality & Compliance for Sandoz/Novartis, Sanofi-Aventis and SB, which also included Regulatory Inspection Preparation and Management responsibilities. Having been involved in approximately 300 FDA Inspections throughout my career, I have resolved multiple Warning Letters, along with two Consent Decrees, allowing for the lifting of production and shipping restrictions