Education:
1978 BSc. (Pharmacy): University College Dublin
1979 Membership of the Pharmaceutical Society of Ireland (M.P.S.I).
1984 Ph.D. (Pharmacy): Trinity College Dublin.
1990 Certified Diploma in Accounting & Finance: ACCA.

2021-Present: Eliquent Life Sciences (Partner)
• Assess and enhance quality strategy, organization structure, quality culture, quality systems and regulatory inspection readiness of global operations involved in the development, manufacture and distribution of drugs and medical devices.
• Develop and deploy of fit-for-purpose quality systems to achieve compliance with global (e.g. FDA, EMA) regulatory authority GMP/GDP requirements.
• Monitor and enhance manufacturing site Quality performance.
• Improve quality function efficiency and effectiveness.
• Establish and direct QMS and Quality Culture assessments and develop pragmatic quality improvement plans.

2021: Humanitarian Support
• Developed and delivered training programmes, in English and French, on cold and ultra-cold chain distribution of COVID-19 vaccines to UNICEF/WHO operations in low- and middle-income countries.
• Provided on-the-ground support to African countries on the storage and transportation of COVID-19 vaccines and handling of medical waste.
• Member of the Independent Product Group, an advisory body to COVAX (GAVI Facility).

2018-2021: Pfizer | VP Global Quality Operations, Biotech & Small Molecules and Data Integrity
• Provided quality oversight and strategic and tactical leadership of all Biotech, API and Solids manufacturing sites, resulting in high levels of performance.
• Led the development and deployment of the Data Integrity Programme for all manufacturing sites.

2013-2018: Pfizer | VP, Global Manufacturing Site and Logistics/Supply Quality Operations
• Quality oversight responsibility for over 60 internal Pfizer manufacturing sites (Biotech, Small Molecule, and Consumer Healthcare) and distribution network, involving over 4,000 Quality function colleagues.

2012-2013: Pfizer | VP, Global Quality Strategy and Affiliate Quality Operations
• Established a global Affiliate (Pfizer Country Office) Quality Operations organization with representatives in over 40 countries.
• Acted as Pfizer Quality Operations representative for European Federation of Pharmaceutical Industries and Associations (EFPIA) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

2000-2012: Pfizer
• Quality Operations roles of increasing responsibility, including Quality Leader for API Sites; Director of Contract Operations Quality Assurance for Europe (200+ CDMOs) and quality oversight of Product Development Unit activities.

2008-2021: Pfizer | VP Global Quality Operations
• Roles included quality oversight and strategic and tactical leadership of all manufacturing sites (60 + Biotech, Small Molecule, and Consumer sites), Logistics/Supply network and global affiliates (30+ country offices); head of global quality strategy and representative for European Federation of Pharmaceutical Industries and Associations (EFPIA).

2000-2012: Pfizer
• Quality Operations roles of increasing responsibility, including
Quality Leader for API Site; Director of Contract Operations Quality Assurance for Europe (200+ CDMOs) and quality oversight of Product Development Unit activities.

1992-1999: Baxter Healthcare
• Quality Manager, Ireland Manufacturing; Director of Quality, Renal Division Europe.

1982-1991: Yves Rocher
• Quality Manager, Cork, Ireland manufacturing operations.