Basel Area, Switzerland
Division Head, GMP Auditing at Novartis Vaccines
Pharmaceuticals
Education
University of Pennsylvania School of Medicine 2003 — 2007
MS, Cell and Molecular Biology
University of Notre Dame 1999 — 2003
BS, Biochemistry
Experience
GSK January 2015 - Present
Novartis Vaccines and Diagnostics January 2014 - December 2014
Novartis Vaccines and Diagnostics September 2012 - December 2013
Ajinomoto North America, Inc. October 2011 - August 2012
Hospira June 2011 - October 2011
Baxter Healthcare November 2009 - June 2011
Baxter Healthcare January 2009 - November 2009
Baxter Healthcare June 2008 - January 2009
Baxter Healthcare May 2007 - June 2008
Skills
ISO, Lean Manufacturing, Management Review, cGMP, Change Control, FDA, Computer System..., GDP, 21 CFR Part 11, Supplier Management, Complaint Management, Cleaning Validation, V&V, Regulatory Affairs, Medical Devices, Cross-functional Team..., FDA GMP, Quality Control, Quality System..., SOP, Quality System, Internal Audit, Trackwise, Quality Auditing, GMP, Metrics Reporting, LIMS, Sop, ISO 13485, ISO 14971, 21 CFR, Validation, Quality Assurance, Software Documentation, Quality Systems, Supply Management, Supplier Quality, GxP, CAPA, Aseptic Processing