With 38 years of experience in the BioTech industry starting in manufacturing, MSAT lab bench, facility design, QA, CQV, process validation, IT and Automation in Germany through 2000. Then IT network technology (IBM), CSV (Baxter), site based validation (MedImmune), facility design/build/CQV and CSV, process automation, IT Quality (AZ), Quality Engineering and finally site Quality Head and executive (Kite).