Patrick O'meara
About Patrick O'meara
Patrick O'Meara serves as the Site Compliance Lead at Kite Pharma, where he oversees compliance with global policies and manages external audits. With extensive experience in the field, he previously held the position of Associate Director of Compliance and Risk Management at Allergan for 16 years.
Work at Kite Pharma
Patrick O'meara has served as the Site Compliance Lead at Kite Pharma since 2021. In this role, he is responsible for developing global policies and procedures to ensure that functional site practices align with these standards. He leads the preparation and management of external audits and inspections, collaborating directly with regulatory investigators. O'meara also directs the site internal audit program to maintain compliance with global Good Manufacturing Practices (GMP) regulations and corporate requirements. His efforts ensure that the site remains inspection-ready, hosting both internal corporate and external agency inspections effectively.
Previous Experience at Allergan
Before joining Kite Pharma, Patrick O'meara worked at Allergan as the Associate Director of Compliance and Risk Management from 2005 to 2021. During his 16 years at Allergan, he gained extensive experience in compliance and risk management practices. His role involved overseeing various compliance initiatives and ensuring adherence to regulatory standards. This experience contributed to his expertise in auditing and risk management, which he has applied in his current position.
Education and Expertise
Patrick O'meara earned a Bachelor of Science degree in Biology/Biological Sciences from Mount St. Mary's University, where he studied from 1991 to 1995. His educational background provides a strong foundation for his work in compliance and risk management within the pharmaceutical industry. O'meara possesses extensive auditing experience, specializing in due diligence, supplier surveillance, and site inspection readiness for regulatory bodies such as the FDA, EMA, ANVISA, and Health Canada.
Quality Risk Management Development
In his role at Kite Pharma, Patrick O'meara has developed various quality risk management tools and models. These tools are specifically designed to assist with audit functions and supply chain risk management. His contributions in this area help to enhance the overall compliance framework and ensure that the site meets regulatory expectations effectively.