Amgen - Siena, Italy since Jan 2013
Director, Global Quality Compliance at Amgen Inc
Novartis Vaccines and Diagnostics - Siena, Italy Jan 2011 - Nov 2012
Head of Compliance, Novartis Vaccines
Amgen - Thousand Oaks, CA 1995 - 2011
Director, Quality and Compliance
Education:
Grinnell College 1980 - 1984
Skills:
Quality Auditing Gmp Capa Change Control Fda 21 Cfr Part 11 Validation Sop Biopharmaceuticals Pharmaceutical Industry Regulatory Affairs Gxp Biotechnology Technology Transfer Quality System Aseptic Processing Computer System Validation Quality Assurance Regulatory Requirements U.s. Food and Drug Administration Corrective and Preventive Action Standard Operating Procedure