Joanne Spallone is Global Audit Head for GCP/PV, Global Development Quality, at Novartis. Joanne has 35+ years of experience in the pharmaceutical industry, and has spent more than half her career in the clinical and pharmacovigilance quality assurance field. The majority of her career has been with Novartis (and formerly Ciba-Geigy Corporation), where she has worked a total of 36 years. In her current position, Joanne leads the GCP/PV Audit program for Novartis, including audits of clinical sites, affiliates, service providers and systems/processes.

Prior to re-joining Novartis in December 2006, Joanne worked at Schering-Plough Corporation where she was responsible for establishing a corporate pharmacovigilance audit group. She also worked at ALTANA Pharma from May 2003 until February 2005, where she set up a US clinical and PV quality assurance program.
Joanne has led and managed specialized directed investigations, audits and inspections, and systems and due diligence/licensing audits. She has developed and led GCP/PV training programs for global QA and clinical research personnel.

Joanne was formerly an active faculty member with the Pharmaceutical Education and Research Institute, Inc. (PERI) for approximately 13 years, involved as Co-Course Director for Basic GCP and as a faculty member for the Advanced GCP class. She spent several years on PhRMA’s Bioresearch Monitoring Steering Committee (BRMC) in positions including Chairperson, Vice-Chair, Past Chair and member-at-large. Joanne has presented at several conferences.