Ann O'Connor BSc. Pharm MPSI
OVERVIEW
FOCUS AREAS
AWARDS & RECOGNITION
Over 35 years of global leadership experience in Quality/Regulatory Affairs in multiple positions at the HPRA and in the Pharma and MedTech industry
Corporate and site Quality Operations ensuring compliance with Global GMP/GDP
Regulatory Agency Inspection readiness, performance, remediation in particular the FDA, HPRA and major regulatory agencies
Quality Management Systems
Deviation/CAPA process and Risk Management
Gap assessments covering product lifecycle
Quality Organisation Development
Regulatory strategy
Combination products
Due Diligence
Training
TOPRA Global Communication Award – Nov 2011
Working as a Partner at ELIQUENT Life Sciences providing support to both the MedTech and Pharmaceutical sectors at local and international level. 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 specialization in Governance, Quality and Regulatory Affairs and a history of providing global quality strategic direction and building high performing teams.
Ann spent 18 progressive years at the Health Products Regulatory Authority Ireland (HPRA) and was Medical Devices Director and subsequently Human Products Registration and Licensing Director. During this time, she was a member of the Executive Committee. In 2001 she was responsible for the establishment of the Competent Authority in Ireland for medical devices and in-vitro diagnostic medical devices and was Medical Devices Director for a number of years. She subsequently had responsibility for human medicines licensing activities including innovative medicines, generic medicines, clinical trials. advanced therapies etc. and provided leadership to a diverse group of professional staff. She represented the HPRA on numerous occasions at both European and Global level
Ann moved back to industry in 2014 and was responsible for establishing Grifols Worldwide Operation from Greenfield site to fully licensed GMP/GDP facility and was a member of the Global Executive Committee. She actively worked as a the primary QP/RP for the operation. She moved to Jazz Pharmaceuticals in 2017 and led the Global Quality Team for external manufacturing (contract manufacturing operations) with responsibility for Development, Commercial and Quality Control of products and their related activities. She was a member of the Global Quality Leadership Team and managed a diverse portfolio of products and Team locations.
Ann is currently a Board Director of the Irish Blood Transfusion service in 2023 and also provides advice to innovative start-up companies in Ireland.
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EDUCATION:
- Bachelor of Science Pharmacy, University College Dublin
- Diploma Corporate Governance, Corporate Governance Institute, Glasgow Caledonian University,
Advanced Diploma Personal, Leadership and Executive Coaching, Kingstown College and ICF, EMCC - Certificate in Professional Coaching and Ethics, Kingston College
CERTIFICATIONS:
Member of the Pharmaceutical Society of Ireland
ASSOCIATIONS:
- TOPRA Lifelong Member
- TOPRA Advisory Council 2005-2020
- Member of Corporate Governance Institute, Ireland
- Member of Parenteral Drug Association
- GAMP Ireland Committee member
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PROFESSIONAL EXPERIENCE;
- Jazz Pharmaceuticals – Executive Director Global Quality, External Manufacturing
- Grifols Worldwide Operations – Technical Director and primary Qualified Person and Responsible Person
- 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 primary Qualified Person
- B. Braun Medical – Pharmaceutical Services Manager and primary Qualified Person
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