Sovereign Pharmaceuticals Jun 2008 - May 2011
Vice President Quality and Clinical and Regulatory Affairs
Andrx Pharmaceuticals Apr 2003 - Jun 2008
Vice President Quality and Regulatory Affairs
Miles Technologies Apr 2003 - Jun 2008
President and Owner
Ciba-Geigy 1994 - 1996
Executive Director of Quality and Regulatory Affairs
Eli Lilly and Company 1991 - 1994
Corporate Manager of Quality and Regulatory Affairs
Education:
Kennedy Western University 1990 - 1992
Doctorates, Doctor of Philosophy, Chemical Engineering
Kennedy Western University 1989 - 1990
Master of Science, Masters, Engineering
University of Sussex 1976
University of Minnesota 1971 - 1975
Bachelors, Bachelor of Arts, Physiology
Gmp Institute Hall
University of Sussex
Bachelors, Bachelor of Science
University of Minnesota Medical School
Skills:
Fda Quality Systems Gmp Medical Devices Regulatory Affairs Compliance Biotechnology Clinical Life Sciences Validation Cgmp Pharmaceuticals Capa Process Validation Iso 13485 Quality Assurance Six Sigma Technology Transfer Problem Solving Strategic Planning Process Improvement Manufacturing 21 Cfr Part 11 Quality Auditing Quality Management Glp Quality Engineering Continuous Improvement Gxp Root Cause Analysis Auditing Pharmaceutical Industry V&V Quality Control Regulatory Requirements Quality System Computer System Validation Sop Regulatory Submissions Cross Functional Team Leadership Process Simulation Software Documentation Gcp Commercialization Cro Analytical Chemistry Lifesciences Clinical Research U.s. Food and Drug Administration
Football Aerobics Collecting Antiques Aviation Exercise Nascar Home Improvement Shooting Reading Gourmet Cooking Sports The Arts Golf Fishing Home Decoration Health Watching Sports Photograph Collecting Coins Diy Cooking Gardening Cruises Sewing Outdoors Electronics Crafts Fitness Music Dogs Movies Collecting Kids Medicine Diet Automobiles Cats Walking Travel Career Boating Investing Traveling Smoking Self Improvement Watching Football