Valerie Mulholland

Valerie Mulholland is the Principal Consultant at GMP Services, based in Ireland. With over 25 years of experience in quality, she provides regulatory and compliance intelligence, including training and auditing services, to the biopharmaceutical, pharmaceutical, medical device, and blood transfusion sectors. While primarily serving clients in Ireland, Valerie has also worked extensively across the EU, US, and Mexico.

Valerie recently earned a PhD for her groundbreaking research on Effective Risk-Based Decision Making in Quality Risk Management, conducted with the Pharmaceutical Regulatory Science Team (PRST) at TU Dublin. She has published 13 academic papers and has presented on topics such as risk science, risk-based decision-making, and knowledge management at national and international conferences. Notably, four of her publications were developed to support the work of ICH, and her research and training material is incorporated into the ICH Q9 (R1) training materials. Valerie's expertise has gained significant recognition, leading her to speak internationally and alongside regulatory agencies such as EMA, FDA, and ICH.

Combining years of experience as a pharmaceutical consultant and auditor with her in-depth research into the Science of Risk and Knowledge management.  Valerie explored both academic research and practical applications across, Pharmaceutical, Medical device and other high-risk industries, such as aviation and nuclear.

Valerie's work in this area,  provides valuable and groundbreaking insights into how risk-informed and risk-based decision-making can drive excellence in pharmaceutical quality management.

Valerie specializes in the design and delivery of specialized GMP, Quality, and Regulatory training programs. Her training solutions are tailored to maximize learning and engagement while ensuring operations and personnel remain up-to-date with the latest compliance and regulatory requirements. All training programs are bespoke, designed specifically to address the unique needs of each organization, and delivered in a relaxed and engaging manner, incorporating interactive elements such as case studies, stories, quizzes, and gamification techniques to enhance retention.

As a Lead Auditor, Valerie has extensive experience across a wide range of manufacturing technologies, suppliers, distributors, and service providers, ensuring compliance with EU, FDA, MHRA, TGA, WHO, and other international regulatory standards. A qualified microbiologist, she possesses expertise in:

Upstream & downstream manufacturing

Aseptic filling and sterilization

Solid and oral dose manufacturing

API manufacturing

Quality management systems

Data integrity and analytical methods

Microbiology and validation

Computer system validation

Quality improvement projects and design

In the medical device sector, Valerie is a certified Lead Auditor to ISO 13485:2016, ISO 9001:2015, and MDSAP, with experience in MDR implementation, audit coaching, and training. Additionally, she provides pre-PAI and regulatory audit assessments.

Valerie is a part-time lecturer at TU Dublin and remains actively involved in professional organizations. She previously served as secretary of the Irish Chapter of the PDA and has moderated PDA events for many years. Valerie frequently collaborates with regulators and industry experts to stay at the forefront of emerging trends in biomanufacturing.

She is also a co-host on the Risk Revolution Podcast, where she discusses critical topics in pharmaceutical risk management.