Experience

LGC Clinical Diagnostics

• United States
• Biotechnology
• 1 - 100 Employee

• Senior Vice President Quality and Regulatory Affairs

  • Mar 2022 - Present



Technopath Clinical Diagnostics

• Ireland
• Hospitals and Health Care
• 1 - 100 Employee

• VP of Quality and Regulatory Affairs

  • May 2018 - Present

  • Provide overall strategic direction and leadership to the Quality and RA function to ensure efficient interface between Manufacturing, Distribution, Research and Development, Marketing and Sales • Lead the Quality Organisation at Technopath Clinical Diagnostics (Quality Assurance, Quality Control Laboratory, Quality Systems, R&D QA, Regulatory Affairs & Labelling and Technical Services) to ensure that quality and regulatory compliance requirements are meeting business demands • Responsible for applying and maintaining a compliant Quality System per ISO and FDA requirements. Represent the company during regulatory agency audits and inspections. • Responsible for strengthening the quality systems and for determining the appropriate infrastructure and resources required to achieve the company's objectives. Show less



Technopath

• Ballina, Co. Tipperary, Ireland

• Head of Quality & Regulatory Affairs

  • Jan 2014 - Present



Technopath Clinical Diagnostics

• Ireland
• Hospitals and Health Care
• 1 - 100 Employee

• Head of Quality and Regulatory Affairs

  • 2014 - 2016



Abbott Laboratories

• Longford, Ireland

• Associate Global Compliance Manager

  • Apr 2013 - Dec 2013

  1. Conduct Audits across the Abbott Diagnostics Division Manufacturing Sites network and Audits at the Commercial Affiliate Sites of Abbott Diagnostics, Abbott Molecular and Abbott Diabetes Care to assess compliance to all applicable current External Standards and Regulations as well as Abbott Quality System requirements. 2. Prepare and Support Abbott facilities for Inspection Readiness (FDA, ISO etc.). 3. Responsible for the Management of the Affiliate Compliance Professionals. 1. Conduct Audits across the Abbott Diagnostics Division Manufacturing Sites network and Audits at the Commercial Affiliate Sites of Abbott Diagnostics, Abbott Molecular and Abbott Diabetes Care to assess compliance to all applicable current External Standards and Regulations as well as Abbott Quality System requirements. 2. Prepare and Support Abbott facilities for Inspection Readiness (FDA, ISO etc.). 3. Responsible for the Management of the Affiliate Compliance Professionals.



Abbott & Associates Inc. - Professional Placement

• United States
• Staffing and Recruiting
• 1 - 100 Employee

• Site Internal Auditor

  • Mar 2011 - Mar 2013



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Validation Manager

  • Feb 2007 - Mar 2011