Based in Ireland and an Engineer by education, he has held Engineering, Management, and Executive Director positions across Services/Systems Integrator and Life Sciences companies in addition to his independent consulting practice. His focus is building compliant holistic & integrated digital environments to enable the manufacture and distribution of critical patient therapies & devices through repeatable techniques and solutions. This includes strategic systems planning, digital maturity assessment, requirements analysis, quality risk management, system selection & vendor audits, project & program management, functional architecture design, and training in GxP computerized systems good practice, regulations, & data integrity. He has managed the business justification, strategic planning, & rollout of multiple integrated digital manufacturing projects/programs across different vendor solutions and life sciences manufacturing modalities for both greenfield/brownfield and mature manufacturing environments. His local & global voluntary work includes ISPE GAMP, Special Interest Groups (including global ISPE MES SIG working group), and speaking/guest lecturing in GxP Manufacturing Digital Transformation