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Tony McDonagh

Senior Associate

Tony is an experienced Enterprise CSV/DI and IT Applications consultant with over 35 years experience implementing and supporting business and Quality Systems across a variety of Life Science companies.  He brings a wealth of practical experience across digital Laboratory and Quality System operations, ERP, Manufacturing and Supply Chain, Pharmacovigilance, Clinical Trials Management systems and Product Serialization systems.   

Key Skills & Experience

  • 35+ years Life Science and Laboratory & Quality Systems and Computer Systems Validation compliance experience;

  • Digital transformation to the Cloud;

  • Data Integrity assessment and remediation implementation;

  • CSV and DI Training Experience for small, medium and large size organizations;

  • FDA Readiness review and audit support.

  • IT Compliance and Computer Systems Validation experience across Pharma, Bio Pharma and Medical Device industries;

  • Executive leadership having acted as Vice President, CIO and Executive Director for over 10 years held at Elan Pharmaceuticals, Novartis Global Shared Services  and Alexion;

  • CSV and Data Integrity Consultants for companies including Forest Labs, Merck KgAa, Abbott, Pfizer, Takeda, Stallergens, Centrient, BPL and others;