SHREE Nexus Advisory Group
Dr. Hugh O’Neill
Vice President, Quality and Operations
PHARMASEAL
United Kingdom
Pharmaceutical quality and operations leader with more than 30 years of experience across life sciences, regulated technology, computer system validation and quality management.
Background
Professional perspective
Hugh O’Neill is a PhD scientist and pharmaceutical industry professional with more than 30 years of experience spanning life sciences, technology, quality management and regulated operations.
During his career, Hugh has worked with major global pharmaceutical companies and contract research organisations, developing, implementing, validating and supporting computerised systems within highly regulated environments. His experience combines scientific understanding with extensive operational, technology and quality-management expertise.
Hugh has significant experience in computer system validation, quality management systems, regulatory compliance, audit and inspection readiness, business process improvement and the implementation of validated systems. He is also an experienced and qualified project manager, with a track record of delivering complex initiatives across pharmaceutical and life-sciences organisations.
Alongside his industry roles, Hugh has been actively involved in the professional quality community, including participation in the Research Quality Association's IT Committee. His work brings together practical pharmaceutical operations, technology governance and the quality and compliance disciplines required to operate effectively in regulated life-sciences environments.