With a global network of over 90 GxP consultants, PharmaLex Ireland has the bandwidth to support the diverse demands facing our clients.

Accelerating and innovating compliant patient care

Our Team

Meet some of our team

Ann McGee, B.Sc.(Pharm), M.Sc., MPSI

Managing Director & Principal Consultant, Quality and Compliance

+ 353 (0)1 846 4742

Ann qualified as a pharmacist from Trinity College Dublin in 1983 where she also obtained a research M.Sc in Science, working in the area of pharmacognosy.
Ann has more than 30 years’ work experience divided between the pharmaceutical industry and as a regulator. Ann’s industrial experience spans the areas of Clinical Trials, Regulatory Affairs, Product Development, Quality Assurance and Regulatory Compliance, Technical Management and as a Qualified Person.
As a regulator, Ann worked as a Senior Inspector with the Health Products Regulatory Authority (HPRA, formerly the Irish Medicines Board) and inspected nationally and internationally on behalf of the EMEA for GxP compliance. Ann acted as Registrar and Secretary (CEO) of the Pharmaceutical Society of Ireland, the statutory body governing the profession of pharmacy in Ireland. The remit of the Society includes the education and registration of pharmacists and the monitoring and enforcement of standards of Good Pharmaceutical Practice. Her varied and extensive experience equips Ann with an in-depth knowledge of Quality Management Systems and of the regulatory compliance standards and requirements across all area of best practice (GxP). Ann has actively participated at national and international level in initiatives impacting the healthcare area including the development of legislation and GMP guidance impacting the pharmaceutical sector. She was elected and acted as Vice-Chairperson of the PIC/S and took an active part in the development of a number of PIC/S guidance documents, some of which have since become annexes to the EU GMP Guide.
Ann has obtained a number of additional qualifications in various subject areas of interest during her career to date and is firmly committed to her own continuing professional education. She is a member of a number of professional associations including ISPE and The Pharmaceutical and Healthcare Sciences Society (PHSS). She is also a member of the Committee of the Irish Chapter of the Parenteral Drug Administration (PDA) and of the European QP Association Expert Panel on GDP.
Ann won the Services category, Small Firms Association National Awards 2013. She was also named the Enterprise Ireland WMB Female Entrepreneur of the Year 2012.

Colette Dolan

Director, Head of Quality & Compliance

+ 353 (0)1 846 4742

Colette qualified from University College Dublin with a B.Sc. (Hons) in Industrial Microbiology and subsequently studied at Trinity College Dublin where she obtained QP Status. 

Colette has over 30 years’ experience in the pharmaceutical manufacturing sector with senior leadership roles in Quality, Operations and Supply Chain in Mylan Dublin and as Quality Manager at Rottapharma Ltd and Quality Systems Manager at Organon

 Colette is a highly motivated individual with exacting standards of personal performance and a demonstrated ability to meet business objectives and deliver change through cross-functional teams in a collaborative manner.

Our Associate Consultant Panel

Meet Some of our Associates

John Bourke

Associate Consultant

+ 353 (0)1 846 4742

John Bourke MSc MPSI is a business associate of PharmaLex Ireland. John has worked in various roles in Pharmacy over the last 25 years. A proprietor pharmacist over many years, he has wide experience in retail pharmacy. In particular John has considerable experience working with quality systems having developed an externally accredited quality system in his own pharmacy. John has worked as consultant for a large chain of pharmacies with responsibility for quality systems and training and development (Network Manager for pharmacy Xcelerate Skillnet). John is past President of the Pharmaceutical Society of Ireland and Chair of the PSI Law and Ethics Committee.

Fionnuala Burke

Associate Consultant

+ 353 (0)1 846 4742

Fionnuala qualified as an Industrial Microbiologist from University College, Dublin in 1988, where she also obtained an M.Sc. in Industrial Microbiology. In 2012 she obtained an M.Sc. in Industrial Pharmacy from RCSI, Dublin, where she received the Abbott medal for academic excellence; she is qualified to act as a Qualified Person. Fionnuala has over 20 years’ industry experience. As a pharmaceutical consultant she has provided assistance in the preparation of sterile and oral dose manufacturing sites for impending regulatory inspections. Fionnuala is a Certified Auditor and Trainer and was also a lecturer in DIT, Dublin

Muiris Dowling

Associate Consultant

+ 353 (0)1 846 4742

Muiris graduated from Dublin College Cork in 1988 with a MB, BCH, BAO and is a member of the Royal College of Practitioners (MRCGP) since 1992. During his career Muiris has worked in GP practices both in Ireland and England. Since 1999 his experience has involved acting as as a Medical Director, QPPV and an Investigator.

Muiris has over 10 years‘ experience conducting clinical trials to GCP standard on behalf of pharmaceutical companies from the EU, USA and Turkey. Since 2008 Muiris has provided contract medical services to the HSE and contract Pharmacovigilance, training and medical review services to the pharmaceutical industry.

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