Experience

The Quality Risk Management Institute

• Ireland
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Founder

  • Feb 2021 - Present

  The mission of the QRMi is to enhance patient safety in the biopharma industry through the promotion of effective Quality Risk Management and the professionalisation of QRM across all roles.



BioPharm Excel

• Ireland
• Pharmaceutical Manufacturing

• CEO

  • Aug 2018 - Present

  Driving Biopharma Innovation: We assist organisations to think and act more creatively to achieve excellence-led, practical solutions to the challenges involved in assuring the global supply of high-quality human drug products, medical devices and diagnostic products. Our focus is on achieving quality excellence through the integration of cultural excellence, knowledge excellence and operational excellence.



TU Dublin

• Arnold F. Graves Scholar

  • Jan 2020 - Present

  Post Doctoral Research to enhance the impact and effectiveness of QRM practices in the BioPharmaceutical Industry and to advance Risk-based Decision Making capabilities.



Technological University Dublin

• Ireland
• Education Management
• 700 & Above Employee

• Adjunct Research Fellow Regulatory Science

  • Mar 2015 - Present

  I direct and lead a range of research projects in the field of pharmaceutical regulatory science at PhD and Masters level. In addition, I am actively involved in conducting post doctoral research for global regulatory agencies in the areas of quality metrics, quality culture, product recalls and quality defects.



Lachman Consultant Services

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Associate

  • Apr 2017 - Aug 2018



Technological University Dublin

• Ireland
• Education Management
• 700 & Above Employee

• Regulatory Science Researcher & PhD Candidate

  • Jan 2011 - Jan 2015

  The Development of a methodology for implementing the recent ICH Q8 (R2), Q9 and Q10 regulatory guidance providing an integrated science and risk based approach to Product Development, Quality Risk Management and Pharmaceutical Quality Systems used in the production of human drug products.



PM Group

• Ireland
• Architecture and Planning
• 700 & Above Employee

• Principal Consultant Life Science

  • Jun 2005 - Nov 2009

  I worked with a broad range of international clients providing new facility design, start up, commissioning and qualification and regulatory consultancy services.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• ICV Area Manager - Drug Product

  • 2002 - 2004

  Overall responsibility for organizing and managing the cross functional Integrated Commissioning and Validation (ICV) teams within in Drug Product Grange Castle facility start Up for Utilities, Suite 2 Sterile Vial filling facility and Suite 3 Laboratory facility



Elan Pharmaceuticals

• Ireland
• Biotechnology
• 300 - 400 Employee

• Project Manager, Global Engineering

  • 2000 - 2002

  Athlone Expansion Project - Process Project ManagerManagement of the Process and Equipment designManagement of Vendor SelectionManagement of Procurement process : Budget US $ 60 millionManagement of the installation, commissioning and validation of all Process Equipment in both the new Pharmaceutical Tabletting Facility and the Upgraded Pivotal /Pilot plant.



LEO Pharma

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Engineering Services Manager

  • 1996 - 2000

  Responsible for a team of providing:Process Controls Services for Projects & Manufacturing Support Process Optimisation Computer Systems ValidationInstrumentation, Calibration & Maintenance Management servicesResponsibilities included budget control, resource scheduling, project planning and management. Participation in Cross Functional management teams for the strategic planning, project execution, new product introductions and operational efficiency programs. Operational site management for day to day operations and preparation for and participation in various on site audits conducted by FDA, IMB, EPA and HSA