Tony McDonagh is a Partner with Validant, based in the EMEA region.
Tony is an experienced Quality and IT consultant with over 35 years experience spent in the Life Science industry.
As a Partner at Validant. Tony supports clients across electronic Data Integrity, IT Lab Systems, IT Enterprise Applications & CSV Programs.
Initially employed as an Analytical Chemist at Syntex ( now Roche) Tony migrated to the world of IT during the implementation of a global LIMS, Chromatography and Laboratory robotics projects and onto global applications such as SAP. He is a Certified LIMS and SAP consultant and he has presented many papers on IT Systems Validation and 21 CFR part 11.
Prior to consulting, Tony was VP of IT Global Applications & Project Mgt at Elan Pharmaceuticals where he headed the Global SAP /LIMS program across 14 sites. While at Elan he lead the corporate 21 CFR Part 11/Data Integrity assessment and remediation program.
As an IT Compliance and CSV consultant Tony has worked with many of Pharma, BioPharma and Medical Device companies including : Pfizer, Forest Labs (now Allergan), Schering Plough, Merck KGaA, Abbott Diagnostics, Serono, Centrient, Advanced Medical Systems, United Drug, Takeda and Amryt.
More recently Tony was the Executive Director IT Global Operations at Alexion and lead an electronic Data Integrity program for Alexion across five sites (US and Europe) from initial assessments to their subsequent remediation. Prior to this he was CIO & Head of IT for Novartis GBS (Global Business Services) in Dublin.
Tony brings a wealth of experience across business process compliance, electronic Laboratory and Quality System operations, Supply Chain and Distribution processes, product Serialization and IT Quality Systems, Risk Based Computer systems validation and Data Integrity.
Tony is an integral part of the Good Automated Practices GAMP forum Ireland and has helped many international companies assess their electronic Quality Systems and subsequently devise and implement a Laboratory and Quality Systems IT strategy & compliance remediation program.
At Validant, Tony has been involved as a CSV and Data Integrity Assessment and remediation lead consultant and Due Diligences for M&A targets.