Charlie Wakeham
Career
2024 Director at WakeUp to Quality
- Resolving Quality and Compliance challenges in a GxP world through consultancy and training
2023 - present Chair of ISPE GAMP® Global Steering Committee
- Leading a volunteer community of 5,000 professionals focused on computerized systems validation and data integrity
2023 Global Head of Quality and Compliance at Magentus, Australia (formerly Citadel Health)
- Global responsibility for improving organizational quality, implementing project quality, and safeguarding data privacy to DPA/GDPR
2013 - 2022 APAC GxP Compliance Manager at Waters Corporation, Australia
- Delivering data integrity consultancy, CSV assistance, and periodic review services to regulated companies, and assessing and advising on their quality systems, working practices, SOPs and data governance
- Implementing and managing validation services across Asia Pacific (APAC) in support of GxP-regulated Waters Empower and NuGenesis customers
1997 - 2013 Project Engineer through to R&D Manager at Pall Life Sciences, UK (now Cytiva)
- Design (process, mechanical, software and hardware), development and validation of GxP-critical process control systems, laboratory computerized systems and single-use bioprocessing systems
- Quality responsibilities including maintenance and implementation of QMS and SOPs, Risk Management, and internal and external auditing
Qualifications, Affiliations, and Training
- ISPE Qualified Instructor 2023
- Fellow of the Institute of Mechanical Engineers 2010 – 2020
- Chartered Engineer 2001 – 2020
- Quality Management Systems Lead Auditor 2012
- Management of Risk and Uncertainty 2008
- Project Management APMP 2003
- Master of Science, Advanced Manufacturing 1997
- Bachelor of Engineering, Mechanical Engineering 1996
ISPE Leadership Roles
- Chair of ISPE GAMP Global Steering Committee
- Chair of ISPE GAMP South Asia Steering Committee
- Leader of ISPE GAMP Global Computer Software Assurance (CSA) Special Interest Group
- Member of ISPE Guidance Documents Committee
- Member of ISPE Annual Meeting Planning Committee