Ireland
Senior Vice President & Chief Quality Officer at Alexion Pharmaceuticals, Inc.
Biotechnology
Education
University College Dublin 1981 — 1985
B.Sc, Microbiology
Open University, UK
MBA, (Strategy; Finance; Creativity, Culture & Change; Marketing)
Trinity College, Dublin
M.Sc
Trinity College, Dublin
Dip. Pharm. Man. Tech (QP)
Experience
Alexion Pharmaceuticals, Inc. June 2014 - Present
Alexion Pharmaceuticals, Inc. December 2013 - June 2014
Genzyme Corporation December 2009 - November 2013
Genzyme May 2010 - October 2010
Genzyme January 2002 - December 2009
Aventis January 1996 - January 2002
Irotec Laboratories May 1993 - December 1995
Howmedica, Pfizer Hospital Products September 1987 - May 1993
Skills
Lifesciences, Medical Devices, Microbiology, Biotechnology, Quality Assurance, Quality Control, Qualified Person, Pharmaceutical Industry, ICH guidelines, Equipment Qualification, 21 CFR Part 11, SOP, Quality Auditing, Clinical Development, Quality Management, Quality System, Technology Transfer, FDA GMP, Deviation Management, Cleaning Validation, Biopharmaceuticals, cGMP practices, Clinical Trials, Drug Delivery, Deviations, IND, Manufacturing, Regulatory Affairs, Aseptic Processing, GxP, Pharmaceutics, TrackWise, GLP, Computer System..., Quality by Design, GAMP, GCP, Contract Manufacturing, V&V, Trackwise, Regulatory Submissions, Regulatory Requirements, Analytical Chemistry, Validation, FDA, LIMS, Sterilization, GMP, Change Control, CAPA