GMP Services                      
Dr Valerie Mulholland 

Valerie Mulholland is the Principal Consultant and CEO of GMP Services, Ireland's leading compliance partner for the global life sciences industry.
With over 25 years of experience, she provides strategic regulatory training and guidance to clients across the bio-pharmaceutical, medical device, and blood transfusion sectors in Ireland, the EU, the US, and Mexico.
Valerie is renowned for her deep technical knowledge and her practical, solution-oriented approach to complex quality challenges. Her curiosity as to why the industry had not taken advantages of the opportunities ICH Q9 seemed to offer, led her to begin a PhD with the Pharmaceutical Regulatory Science Team (PRST) in TU Dublin.

The Research Foundation: From Industry Problem to Global Impact

Valerie's work is driven by a pivotal question:
Why did progress in effective Quality Risk Management stall after its introduction?
Her doctoral research tackled this question directly, examining the human, organizational, and decision-science factors limiting QRM's potential.
This groundbreaking work, which also explored RBDM in other high-risk industries, produced 13 academic publications and a thesis that became a key reference for global standards.

The Impact

  • Her research was used to inform the ICH's deliberations on ICH Q9(R1).

  • It is now referenced in the official ICH Q9(R1) training materials.

  • In January 2025, she was invited by PIC/s to educate international regulators on ICH Q9(R1) at the EMA headquarters.


Current Focus & Industry Leadership

Valerie is at the forefront of the field's evolution, actively shaping its future through research, training, and industry dialogue. Her current explorations include:

  • Developing on-demand training courses on Decision Science for Pharma, focused on mastering Risk-Based Decision Making.

  • Continued material development for explainable AI and human-in-the-loop decision making.

  • Optimizing decision review cadences within the PQS.

  • Building resilience for high-stakes choices.


Selected Leadership Roles

  •  Board Member, PDA Global Regulatory Affairs & Quality Advisory (RAQA).
  • Lecturer on RBDM for the Masters in Validation and Quality Assurance at TU Dublin.
  • Co-host of the Risk Revolution podcast.

Translating Theory into Action: Education & Advisory

A sought-after educator and speaker, Valerie is renowned for her ability to translate complex theory into actionable, defensible practice.

  • For Teams & Individuals: She has created an on-demand suite of courses on Decision Science for Pharma, providing foundational knowledge in Critical Thinking and advanced mastery of Risk-Based Decision Making (RBDM).

  • For Organizations: She designs and delivers interactive training courses, workshops, and town halls that transform deep theoretical understanding into practical decision architectures for the industry.

  • For Senior Leadership: She advises executives on aligning QRM, document governance, and data integrity with clear decision accountability and strategic oversight.


The Mission

Her mission is clear: to help you build decisions you can defend with confidence, and then scale that capability with technology.

Valerie brings a unique blend of academic rigor, practical clarity, and unparalleled regulatory credibility to every engagement.


Write your awesome label here.

Dr Valerie Mulholland

Valerie's LinkedIn Blog

In her LinkedIn blog, Valerie dissects complex regulatory concepts into actionable insights, helping to guide decision makers.

Available on you-tube and wherever you STREAM your podcasts 

Risk Revolution Podcast

The goal of the risk revolution podcast is to advance the maturity of risk management practices within the industry by discussing topics that challenge quality professionals. We seek opportunities to improve and advance the ways in which we perceive and manage risk. The hosts are Nuala Calnan, Valerie Mulholland and Lori Richter.
Write your awesome label here.


Dr Valerie Mulholland, 
Published Academic Papers.

PHD Theses, by Valerie Mulholland 

Effective Risk-Based Decision Making in Quality Risk 
Management 

Link to publisher
Steps towards Demystifying Risk-Based Decision Making.
Authors, Mulholland, V., Greene, A. (2024)
Pharmaceutical Technology, Volume 48, No. 4, p 32-39, April 2024

Link to publisher
Improving RBDM Effectiveness: Addressing Uncertainty.
Authors, Mulholland, V. Greene, A., Lipa M. (2023).
KENX Insight, Volume 3, Article 5


Link to Publisher
Improving RBDM Effectiveness: A Case for Risk Decision Review Points in the Quality Risk Management Process.
Authors, Mulholland, V., Greene, A. (2023). KENX Insight, Volume 3, Article 3
Link to Publisher
Improving RBDM Effectiveness: Determining the Level of Formality. 
Authors, Mulholland, V., Greene, A. (2023).KENX Insight, Volume 3, Article 4


Link to Publisher
Improving RBDM Effectiveness: Insights from Other Industries.        
Authors, Mulholland, V., Greene, A. (2023).KENX Insight, Volume 3, Article 2








Link to Publisher
Integrating Knowledge Management & Quality Risk Management. 
Authors, Lipa, M., Mulholland, V., & Greene, A. (2022).Pharmaceutical Engineering, Vol 42, No 4, July-Aug 2022






Link to Publisher
Advancing competency in managing risk and knowledge: Steps toward operationalisation of the Risk-Knowledge Infinity Cycle (RKI Cycle): Part 3: Uncovering knowledge for QRM through knowledge mapping at node 1.
Authors, Lipa, M., Mulholland, V., & Greene, A. (2022).Technological University Dublin. DOI: 10.21427/DC44-Y431
Link to Publisher
Improving Risk-Based Decision Making (RBDM) Effectiveness Through a Framework which Integrates Knowledge and Risk  Lipa, M; Mulholland, V; and Greene, A.(2022)Level 3: Vol. 16: Iss. 2, Article 2






Link to Publisher
Exploring the Risk-Infinity Cycle (RKI Cycle) across the Product Lifecycle. 
Authors, Lipa, M., Mulholland, V., O’Donnell, K, & Greene, A. (2022).ISPE Case Studies,





Link to Publisher
Steps Beyond Risk Assessment in QRM: RBDM, The next horizon. 
Authors, Mulholland, V; Greene, A; and Lipa, M. (2021)Level 3: Vol. 16: Issue. 1, Article 2. Dec 2021





Link to Publisher
Quality Risk Management – Seeking the Diamonds: Making the Case for Improved Formality in QRM Decision-making.   
Authors, Mulholland, V., & Greene, A. (2020).Level 3: Vol. 15: Issue. 2, Article 18. Dec 2020

Link to Publisher 
QRM: A Case for Convergence: A Reminder that Quality Risk Management must work with other Risk Management Systems. 
Authors, Mulholland, V., & Greene, A. (2020).Level 3: Vol. 15: Issue. 2, Article 21. Dec 2020

Link to Publisher 
Risk Management Tied Up with a Bow Tie.
Authors, Mulholland, V., & Greene, A. (2020).KENX Insight Vol 1 Issue I May 2020







Link to Publisher
testimonials

What our learners say about us

Having attended Valerie's sessions in person, I wondered if the online course would compare. It absolutely does. Her online courses maintain the same engaging, friendly delivery. The material is perfectly paced - comprehensive yet clear and incredibly easy to understand. A pleasantly seamless and effective online experience. Thanks Valerie 
 Grace Walsh
I'm a fan of Valerie's, so I was eager to try an online course and see did it live up to the live experience. Her warm and encouraging teaching style shines through just as brightly. The content is structured so thoughtfully and presented with a clarity that makes learning feel effortless. A truly fantastic job, Valerie!

Mary Gallagher
This courses surprised me. I dislike online courses, - we have a lot of them in our company. But I’ve always enjoyed Valerie's in person sessions, when she is on-site. So I decided to try the first one and I’m thrilled for you Valerie, that the same energy and clear, thoughtful delivery comes through online. Well Done!

Josh O Donovan
Created with