Emergent Biosolutions 2001 - 2004
Vice-President, Qa and Ra
American Red Cross National Testing Lab 1994 - 1999
Qa Officer
Nellcor 1993 - 1994
Compliance Manager
Bioport Corporation Lansing Mi 1991 - 1994
Vice President, Ra and Qa
Fda 1985 - 1990
Investigator
Education:
Western Michigan University Cooley Law School 1988 - 1991
Doctor of Jurisprudence, Doctorates, Law
University of Oklahoma 1978 - 1979
Master of Science, Masters, Environmental Science
Skills:
Capa Project Management Validation Cross Functional Team Leadership Regulatory Affairs Fda Quality Assurance Change Control 21 Cfr Part 11 V&V Process Simulation Medical Devices Gmp Chemistry Lifesciences Glp Sop Clinical Trials Pharmaceutics Biotechnology R&D Quality Auditing Biopharmaceuticals Quality System Pharmaceutical Industry Technology Transfer Regulatory Submissions Iso 13485 Computer System Validation Regulatory Requirements Vaccines Clinical Development Cro Drug Development Gxp Analytical Chemistry Aseptic Processing Hplc Gcp Quality Control