Heather is a Director of TenTenTen Consulting Limited based in the UK, where she is responsible for delivering specialist computer system validation consulting services on a global basis within the life science industry by providing advice and support to overcome the business and regulatory challenges to patient safety, product quality and data integrity. Heather also provides mentoring and coaching services and is a member of the International Coaching Federation.
Heather has 30+ years of experience working in the pharmaceutical industry and previously worked at GlaxoSmithKline until 2022. She fulfilled several global roles in various functions at GSK with her most recent role being Director, Computer System Quality Assurance within the Global Quality Assurance organization where she was responsible for working within tight budgetary constraints to develop and implement strategy, policy and objectives that fundamentally raised the importance of computer system quality and compliance within GSK; identified potential computer compliance risks by interpreting changes in the regulatory environment and translating the impact to GSK. In previous roles, she led quality improvement initiatives based on feedback and metrics, liaised with global suppliers and service providers of GSKs computer systems to address and overcome issues, managed GSK’s IT Quality Management System and provided mentoring and coaching to staff throughout GSK. She is a very experienced leader of high performing teams and is a quality driven individual who prides herself on success.
Heather has been involved with ISPE since 2001 and is currently Chair, GAMP Global Steering Committee and is a Past Chair of the GAMP Europe Steering Committee. Heather was Co-Lead of the Authoring team for ISPE GAMP® 5 Guide Second Edition and GAMP® Good Practice Guide: Enabling Innovation and has authored several articles in Pharmaceutical Engineering. She has been a member of the ISPE Europe Annual Conference Program Committee, served as GAMP track Lead and has presented at ISPE Annual Meetings. Heather has been a recipient of the ISPE Committee of the Year award for the GAMP Global Steering Committee (2022 and 2016) and the ISPE Europe Annual Conference (2019) and is a strong supporter of ISPE’s Women In Pharma initiative.