January / February 2024

CoP Leader Profile: Charlie Wakeham

Marcy Sanford
CoP Leader Profile: Charlie Wakeham

An ISPE member since 1999, Charlie Wakeham has been active within the ISPE GAMP® community since 2001. A founding member of the GAMP UK Community of Practice (CoP), she is currently Chair of the GAMP Global CoP Steering Committee, one of the leaders of the GAMP Computer Software Assurance Special Interest Group (SIG), and a member of the ISPE Guidance Documents Committee. She has co-led or contributed to nine published ISPE GAMP guides and was co-lead of the Data Integrity SIG. She was also a member of several planning committees for ISPE conferences, including the 2023 ISPE Annual Meeting and Expo.

Charlie’s career in the pharmaceutical industry began when she was working on her postgraduate project for her Master of Science. “It was supposed to be a six-month project building a filter sterilization system for an injectable drug. It was interesting, and I was learning a lot, and I enjoyed being involved with something that was providing a benefit to the community. I ended up staying on with the company for 18 years in a variety of roles.”

After moving to Australia in 2013, Charlie began working for Waters Corporation. As their Asia-Pacific (APAC) GxP Compliance Manager, she set up a professional services group delivering computerized system validation (CSV) and data integrity consultancy. Her validation of Waters’ Empower Chromatography Data System and NuGenesis Lab Management System for customers in Australia, New Zealand, China, Korea, and Southeast Asia brought her a deep understanding of the APAC region’s challenges and opportunities.

After a short spell as Global Head of Quality and Compliance at Magentus (formerly Citadel Health), Charlie is now operating as an independent consultant. Her company, WakeUp to Quality, specializes in resolving quality and compliance challenges for GxP organizations. Her practical experience in quality management systems, CSV, and data integrity is combined with her extensive GAMP knowledge to deliver pragmatic solutions using critical thinking and patient-centric approaches.

“I have always been passionate about making a difference, making things better. I now have the opportunity to bring that to a broader range of companies. My focus is always to understand the customer’s internal processes and intended use and to deliver a solution that is correspondingly fit for purpose, whether it’s a simple standard operating procedure or a complex validation project.”

Charlie says she hears from professionals on a regular basis who tell her GAMP® has helped them with their career. “I co-led, with Lorrie Vuo-lo-Schussler, the production of three GAMP Records and Data Integrity Good Practice Guides—they were published in 2018, 2019, and 2020, and recently I had someone reach out on LinkedIn saying how much these guides help them in their work. It means so much to me that in such a complex and critical area, something we did is still helping people.”

One of Charlie’s goals as Chair of the GAMP Global CoP Steering Committee is to encourage early- and mid-career professionals to get involved. “My advice to emerging leaders is to volunteer, get involved, say yes to every opportunity that presents itself. Don’t worry if you don’t have a clear vision of your career plan. Sooner or later, you’ll find your niche and grow. ISPE has had a tremendous positive impact on my career, and it can do the same for you, if you invest the time and energy to be active in the organization.”

Additionally, Charlie is setting up the Steering Committee for GAMP South Asia for ISPE members in Australia, Indonesia, Malaysia, Philippines, Singapore, Thailand, and New Zealand. In 2019, Charlie was recognized with the ISPE Max Seales Yonker Member of the Year Award for her volunteer work with GAMP and for the training she has provided to regulatory agencies.