Work:
Dendreon
since Aug 2010
Sr. QA Manager, Quality Systems
Wolf Consulting
May 2010 - Jul 2010
Consultant
Poniard Pharmaceuticals
Feb 2008 - Apr 2010
Director, QA
Wolf Consulting
Oct 2007 - Feb 2008
Consultant
Amgen, Inc.
Apr 2000 - Oct 2007
Sr. Project Manager
Immunex
2000 - 2002
QA Manager
CTI
1993 - 1999
QA Manager
Bayer
1985 - 1993
QA Supervisor
Skills:
Quality System, Quality Auditing, Inspection, Training, Private Investigations, Teaching, Validation, Fda, Capa, Sop, Change Control, 21 Cfr Part 11, Gmp, Quality Assurance, Biotechnology, Document Management, Biopharmaceuticals, Pharmaceutical Industry, Manufacturing, Auditing, Quality Control, Trackwise, Cro, Quality Management, Fda Gmp, Contract Manufacturing, Gxp, Gcp, Drug Development, Lifesciences, Medical Devices, Gamp, Design Control, Lims, Regulatory Affairs, Computer System Validation, Aseptic Processing, V&V, Cleaning Validation, Regulatory Requirements, Deviations, Analytical Chemistry, Sop Development, Deviation Management, Sterilization, Cgmp Practices, Biologics, Equipment Qualification, Life Sciences