Quality and Regulatory Affairs professional with senior leadership experience in Pharma and Life Science as well as in Medical Devices. Vast experience with various Authorities and notified bodies like US FDA, EMA, MHRA, ANVISA but also China FDA, Saudi FDA, PMDA, HPRA, TUEV SUED, DEKRA, BSI. 

Lean Quality is my key area of interest, AI and RPA (robotics) for Quality and Regulatory with a successful implementations including CSV for RPA solutions.

Areas of special interest and passion: TQM / TPM (defect free and Toyota Production and Quality Management), IWS, Kaizen, 5S, QA, QS, QM, DQ/IQ/OQ/PQ, AM, PM, Lean Six Sigma
Root cause analysis to the real root cause