Who we are

PharmaLex Ireland is situated right on the coast of Ireland. With a team comprising a number of former EU and US FDA Regulatory Inspectors, we work at a strategic and tactical level with our clients, providing holistic advice, guidance and solutions across the entire product lifecycle.

  • By being a part of PharmaLex, we have the bandwidth to support the diverse demands our clients are facing.
  • We offer immediately accessible support and training to build knowledge and in-house capability, providing them with the tools to make informed decisions and improve operational efficiency.
  • By working with our team, our clients benefit from practical solutions and expert guidance relating to their regulatory challenges.
  • Our clients tell us that one of the greatest benefits of working with PharmaLex Ireland is that not only do they receive excellent advice, but we also work with their teams to implement our recommendations and, in doing so, their teams gain a wealth of expertise and knowledge.

Local Contact

  • Jane Lyons
    Country Manager, Ireland PharmaLex Ireland Suite 2, Stafford House
    Strand Road, Portmarnock
    County Dublin D13 H525
    + 353 (0)1 846 4742

PharmaLex Series “A day in the life of “

My day starts with a large mug of strong coffee and a read through my emails.  As I work with colleagues and clients round the world, I usually have a lot of emails to catch up on in the morning!

The biggest challenge is also something I love about the job! No two days are the same and my priorities can change several times during a single day so I am constantly juggling several activities.

I love the variety involved in my role and the teams that I work with.  We are a very collaborative team that does whatever needs to be done to achieve our common goals.

If I need to email someone, I open a new email straight away and add their name and the subject.  I then make sure that I finish all of the emails and send them before I close my laptop at the end of the day.

I love holidaying in the UK.  I particularly like the South West (Cornwall and Devon) and Yorkshire.

We had a family holiday in the US (New England) a few years ago and it was our best holiday ever.   I would love to go back and discover other areas of the US.

Yesterday’s shortcuts are today’s nightmares.

kate coleman womens day

International Women’s Day

To me it means having the courage to challenge the status quo and to challenge what we do, how we do it and how we conduct ourselves in the workplace. It also means to challenge how women are viewed in the workplace and to challenge any perception that feeds into inequality. It’s far too easy to ignore subtle inequalities where the same message in the same tone can be perceived as aggressive from a women but progressive from a man.

I have faced barriers that are inconsequential when compared to women in other less developed countries and for that I am very grateful for the opportunities I have received. However,  there have been times when I felt I was being held back by how I was perceived because I am a woman. These perceptions included that I was too young, too passionate, too intense, too honest, too direct, too ambitious, not political enough, the list goes on! What has pushed me forwards is the knowledge that these perceptions wouldn’t have existed if I was male. I have had to develop strong confidence in my abilities, even when others have tried to put me down and luckily I have now found my way to a career and a company that truly value me.

I think the pharmaceutical industry is generally a good industry in terms of equality and opportunities for anyone, man or woman. However, if any woman does face discrimination or feels that they are unfairly judged due to their gender, I would advise them to speak up, have confidence in your abilities and talents but also develop self-awareness and self-knowledge so that you know when to push the envelope and challenge and when to listen and take  genuine constructive feedback. I always ask myself “Would a guy get this same feedback in this situation?”, if the answer is yes, then its time to take and listen to the feedback. If the answer is no, then that is the time to challenge.

Women must support each other in industry and unfortunately some women have fallen into the trap of dragging other women down who might challenge or compete with them. We shouldn’t need to compete with each other and I have learnt that there is nothing stronger than having a group of dynamic supportive women on a team in addition to supportive and dynamic men! The team I work with now includes men and women that lift each other up and genuinely want the best for the team and each member in the team. There is no better environment to work in. Women who drag other women down are often pushed into those situations where the culture, particularly at management level, encourages women to feel like they have something to prove, more so than their male peers and that type of environment is never healthy. By supporting each other, we are challenging those toxic environments and it is the only way we can bring about change.

The key to a fulfilling career is finding a job that you enjoy, with a team that not only respects you but that you also have respect for, with likeminded people who see beyond gender and focus on talent and expertise to get the job done. Respect is not only about respecting your work but also respecting that you are a person, with a life outside of work that also needs to be prioritised. If you have to fight everyday to be seen and heard, are knocked down for honesty or are expected to sacrifice your life for work then it is time to take stock and think about what you want and make a change. And the big lesson for me has been that people will only knock you down if they see something in you that makes them insecure, show them empathy and use that knowledge to reinforce your confidence in yourself.

jane lyons country manager ireland

International Women’s Day

I am delighted as a company we are celebrating International Women’s Day.  #ChooseToChallenge is part of our culture in PharmaLex; it leads to innovation and encourages us all to always step up and not to just accept the status quo.  By doing so, we deliver a better service to our clients and also enable our employees to work in a dynamic environment where they are encouraged to use their voice and share their ideas which is extremely important given the ever evolving industry we have the privilege to work in.

I have been extremely lucky in my career and have always worked for companies where gender was not an issue – employees were assessed on their abilities rather than their gender.  I am only aware of one occasion where I was informed many years later that my direct line manager at the time suggested I was not put forward for an executive programme as they assumed I was not interested in career progression as I had young children.  This may or may not have been true, but it was a decision that was mine to make rather than it being made for me.  I learnt from that, the importance of always openly discussing my career goals with my manager to eliminate discrimination based on assumptions.

I have worked in a number of sectors in my earlier career and my first direct experience of the pharma sector was when I joined Ann McGee Consulting in 2008 (now PharmaLex).  I remember the first event we organised and my astonishment at the number of women in senior roles in the pharma industry compared to other sectors I had worked in.  It was an inspiring experience and one which I see on a daily basis within PharmaLex.  It is exhilarating to work in a company where employees are treated as equals regardless of gender, race, sexual orientation or religion.

It is extremely important for women to lift each other up but equally as important for women to lift men up and vice versa.  I truly believe that talent, enthusiasm and commitment are key factors when considering any employee for promotion.  I would like to be assessed on my abilities and to receive recognition/promotion as a result of the work that I do rather than because I am a woman and there is a gender quota to fill.  I believe women and men alike deserve this recognition and wish that neither be discriminated against due to gender.

Believe and you can achieve.  Decide where you want to go and then plan how to get there. Don’t put your career development in the hands of others.  Own it.  Continuous learning and development is key to personal growth and this spills over into professional development.  Be inquisitive, ask questions and challenge the status quo!

ann marie purcell

International Women’s Day

When I compare our times to when my mother had to give up her career as a nurse just because she got married its easy to sit back and say “look how far we have come”.  And we have – but not nearly far enough.  Women are very underrepresented in many walks of life so we need to keep challenging in a world where women do not get the same opportunities as men.

Having worked in Finance for many years I was very often the only woman in the room – and in those instances you have to make a conscious effort to ensure your voice is heard.  I ensure I assert my authority – but always  in the nicest possible way.  And in instances where I feel I have been overlooked I have called it out (at the appropriate time).

One of the key reasons I joined Pharmalex was how well represented women are in senior positions in the company.  In  general I think the Pharma industry is ahead of other industries in terms of representation.  So my advise would be to go for it.

It’s critical.  In my career I have mostly had women managers and all have been brilliant – I have learnt so much from them and they have shared their knowledge.  And I try to emulate that and support the women I have worked with and who have worked for me.

Don’t hesitate and always oversell yourself.  When you see a job spec don’t focus on the areas you don’t have experience in – you can learn what you don’t know.

PharmaLex Brexit Services Q&A with our experts…

  • My career path spans over 25 years in the Pharma industry working in both Ireland and the UK.
  • Starting out as a QC Analyst at the beginning of my career, fresh out of WIT.
  • I have held various roles across Quality Assurance, Quality Systems, Compliance and Validation working across multiple companies in the fields of API’s, Manufacturing (Commercial and Development across various product forms), Storage, Distribution and Transportation.
  • My roles have led to travels around the world auditing in India, US, Europe, Russia and Singapore.  Most recently my career has focused on quality management and oversight of global and outsourced supply chain and acting as an RP on UK Wholesale Dealers Authorisations.

Senior Manager – Consultant supporting the Pharmalex QMC team and based in the UK

  • Showing my age here, but I learned some valuable lessons over the years. Many of these have been from some great Line Managers who have inspired me to develop and learn.
    • There is always an opportunity for learning and continuous improvement, even in the most challenging situations. Treat challenging situations as an opportunity to reflect and improve.
    • General advice, somethings happen for a reason and it works in our favour.
    • Without a Quality Culture in an organisation, its difficult to implement and maintain compliance, within the Pharma industry Quality has to be at the heart of what we do on a daily basis.
  • Always go with your gut feeling, if it doesn’t feel right its probably not and its okay to question and challenge established processes and ways of working.
  • Helping others to be the best they can be through coaching and guidance.
  • Turning challenging situations around.     Although the current challenges associated with home schooling of a 5 year old may change this!

Key members of our team

senio consultanct director quality and compliance
Kate Coleman

Senior Consultant / Director Quality & Compliance, PharmaLex Ireland

Kate has worked in Quality roles in the Pharma Industry up to management level for 16 years, covering several platforms including Biologics, Sterile Fill Finish, Vaccines and Oral Dose. Kate is a practicing QP, a qualified Lead Auditor and an SME in Risk Management, New Facility Design/Start Up, QC and Sterility Assurance.

excecutive vp ireland
Patrick Nieuwenhuizen


Patrick has worked in various Managerial Quality roles in Global Pharmaceutical Companies with over 25 years of experience, covering several platforms including Biologics, Sterile Lyo & Fill Finish, Vaccines and oral Dose. Patrick is a qualified Lead Auditor and SME in Quality Control, Sterility Assurance, New Facility Design / Upgrade, Risk Management

Charley Maxwell
Charley Maxwell

Senior Consultant / Director Quality & Compliance, PharmaLex Ireland

Charley has recently joined Pharmalex as Director QMC and Senior Consultant.  He joins us with 20 years’ experience working in industry in Pharmaceutical and Device manufacturing and importation. His background is B.Sc. In Biochemistry and M.Sc. In Pharmaceutical Manufacturing Technology and he has operated as a QP in Ireland since 2018 for sterile and non-sterile manufacture and third country Importation.

diretor quality and compliance
John Cahill

Director, Senior Consultant, Quality and Compliance, PharmaLex Ireland

John has over 20 years’ experience working in a variety of technical and senior leadership roles including Quality Director, Production Director, MS&T projects and specialist roles at both national and international sites. His leadership experience brings strong capabilities in implementing best-in-class strategies in Operational Quality and Quality Systems.

What our clients say about us

We are working with a number of large pharma companies and are looking to create a consortium of partners to collect feedback on expertise, availability and outcomes. If you would be interested in joining our consortium, please contact us on contact@pharmalex.com.

  • I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.

    Lorraine Henry
    Compliance Lead, Qualified Person, Amneal Ireland Limited