Senior Director of Quality @ (July 2017 - June 2021)
Director Site Quality Operations @ CelgenTek (September 2014 - June 2017)
Sr. Director Quality and Regulatory, Qualified Person @ (September 2011 - September 2014)
Director of Quality @ (April 2008 - August 2011)
Quality Manager and QP @ (January 2002 - January 2008)
Quality Control Manager and QP @ (January 2001 - January 2002)
Quality Assurance Team Lead and QP @ (January 2000 - January 2001)
Laboratories Team Leader @ (January 1999 - January 2000)
Plant Microbiologist @ (January 1997 - January 1999)
Microbiologist @ Antigen Pharmaceuticals Ltd. (January 1993 - January 1997)
Tommy Madden Education
University of Limerick
Master of Business Administration - MBA
2015-2017
Trinity College Dublin
Diploma (Pharmaceutical Manufacturing Technology)
1997-1999
Dublin City University
Bachelor's Degree (Biotechnology)
1988-1992
Tommy Madden Skills
Storytelling
Global Regulatory Compliance
Manufacturing Operations
Clinical Development
Key Metrics
Deadline Oriented
Energetic Leadership
Product Reviews
Reporting
Quality Reviews
Department Management
Regulatory Affairs
Change Management
Auditing
Pharmacovigilance
Drug Development
Regulatory Compliance
Internal Audits
Relationship Building
Manufacturing
Batch Processing
Quality Management
Quality Auditing
Pharmaceuticals
CAPA
GMP
ISO 13485
Pharmaceutical Industry
Change Control
FDA
Sop
Validation
Medical Devices
Biopharmaceuticals
Quality System
Biotechnology
Quality Control
Quality Assurance
Regulatory Submissions
CDMO Oversight
Clinical Trials
Operational Excellence
Organizational Leadership
Quality Improvement
Site Inspections
Sterility Assurance
Technology Transfer
Tommy Madden Summary
Tommy Madden, based in Ireland, is currently a Senior Director, GMP Quality at Prothena Corporation plc. Tommy Madden brings experience from previous roles at Viatris, CelgenTek, Olympus Corporation and Stryker. Tommy Madden holds a 2015 - 2017 Master of Business Administration - MBA @ University of Limerick. With a robust skill set that includes Storytelling, Global Regulatory Compliance, Manufacturing Operations, Clinical Development, Key Metrics and more. Tommy Madden has 2 emails and 3 mobile phone numbers on RocketReach.
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