Ann O’Connor

A pharmacist by background with over 35 years’ experience in senior leadership roles in the Health Products Regulatory Authority (HPRA) and blue-chip multinational companies such as Grifols and Jazz Pharmaceuticals. Ltd. Specific specialisation in Governance, Quality and Regulatory Affairs and a history of providing global quality strategic direction and building high performing teams.

Ann was a member of TOPRA Advisory Council from 2005 -2019 and was the winner of the TOPRA Communications award in 2011. She has also acted as a Preceptor for Pharmacy intern students and is a qualified Executive Coach.

Ann’s experience includes:

• Jazz Pharmaceuticals – Executive Director Quality, External Manufacturing
• Grifols – Technical Director
• Health Products Regulatory Authority – Director of Human Products Authorisation and Registration
• Health Products Regulatory Authority – Director of Medical Devices
• Health Products Regulatory Authority – Medical Devices Project Manager
• Health Products Regulatory Authority – Senior Pharmaceutical Assessor
• Schering Plough – Quality Assurance Manager and Qualified Person
• B.Braun Medical – Pharmaceutical Services Manager and QP

Education / Associations:

• Bachelor of Science (BSc) Pharmacy from University College Dublin, 1979
• Responsible Person Good Distribution Practice
• Qualified Person good Manufacturing Practices
• Lead Auditor training Excellence Ireland, 2003
• Chair and delegates training in preparation for the Irish EU Presidency 2003
• Preceptor for training of Pharmacy students in Ireland
• Advanced Diploma, Leadership and Executive Coaching – 2021
• Diploma, Corporate Governance – 2022

Key Competencies include: Regulatory Inspection Preparation & Management, in particular, the FDA, HPRA, and other Major Regulatory Agencies, cGMP, QA Systems/Control, GMP Compliance, Process, Systems, Data Integrity, Training, Deviations/Investigations, Due Diligence