Heather is Company Director and Consultant at TenTenTen Consulting Limited.
Prior to this, Heather was Director, Computer System Quality Assurance, part of the Global Quality Assurance organisation, at GlaxoSmithKline (GSK) R&D based in the UK. In this role which, she was responsible for developing and implementing strategy, policy and objectives that fundamentally raised the importance of computer system quality and compliance within R&D, identifying potential computer compliance risks by interpreting changes in the internal and external regulatory environment and translating the impact to GSK. Heather had line management responsibility for a global team of professionals who were responsible for delivering the departmental programs for inspection readiness, conducting audits of both internal computer systems and external suppliers/vendors and providing general advice and consultation relating to computer system validation.
Heather has 30+ years of working in the pharmaceutical industry and has fulfilled several roles in various functions at GSK including Information Technology (IT), Human Resources (HR), Computer Systems Compliance, Preclinical Development, Global IT Risk Management, Controlled Document Management Compliance and Global Quality & Compliance. Heather also has experience of conducting external supplier/vendor audits and delivering inspection readiness training.
Heather has been involved with ISPE since 2001 in various roles and is currently Chair, GAMP® Global Steering Committee and was previously Chair, GAMP® Europe Steering Committee. She is a member of the GAMP® Editorial Review Board and has Chaired IT related tracks at several ISPE Europe Annual Meetings. Heather has been a recipient of the ISPE Committee of the Year Award for GAMP® Global Steering Committee (2016) and ISPE Europe Annual Conference (2019).