Ireland
• 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.
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.