Basel Area, Switzerland
Director QA, Group Compliance & Audit, Novartis pharma AG
Pharmaceuticals
Education
Rutgers, The State University of New Jersey-Newark 1991 — 1993
BS, Pre-Medicine
DeVry University 1996 — 1998
AS in Electronic Engineering Technology, Electronics Engineering, 3.7/4.0
Experience
Novartis October 2012 - Present
MSD Animal Health June 2010 - October 2012
Schering-Plough April 2002 - August 2010
Merck April 2002 - August 2010
Alpharma Pharmaceutical Co., Piscataway, NJ 2001 - 2002
Nycomed Amershan 1998 - 2001
Skills
Contract Manufacturing, ICH-GCP, Laboratory, Quality Control, GLP, Biopharmaceuticals, SOP development, 21 CFR Part 11, Clinical Trials, Quality System, Aseptic Processing, Computer System..., Process validation, Software Documentation, Sop, Technology Transfer, Cleaning Validation, GCP, ISO 13485, Quality Assurance, Change Control, GxP, Regulatory Submissions, Chromatography, Investigation, Pharmaceutical Industry, Lean Six Sigma-Yellow..., Regulatory Affairs, Trackwise, Biotechnology, CAPA, GMP, Compliance, HPLC, Pharmaceutics, Regulatory Requirements, Sterilization, Quality Auditing, Analytical Chemistry, CRO, FDA, Validation, Pharmacovigilance, Clinical Development, FDA GMP, LIMS, V&V, Vaccines, GAMP, Equiment Validation