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ITS' Tutor's Experience

ITS' Tutor's Experience

Dr Jennifer Thompson – Professional Profile

Regulatory Compliance Services Manager, Dr Jennifer Thompson, is a highly effective project manager and regulatory compliance specialist with a background in computer systems validation, information services and systems, computerised systems governance, on-line analytics, quality management (ISO 9000), cGMP, validation and IT infrastructure controls.

She gained her extensive knowledge in this specialist area through over 20 years’ experience in scoping, planning and delivering pharmaceutical regulatory compliance projects in the UK, Europe and the USA, working with large corporates and smaller companies including GlaxoSmithKline, Novartis Healthcare (UK and Europe), IBM (USA and UK), AstraZeneca, GE Healthcare, Elan Pharmaceuticals, Hoffman La Roche, Pfizer and Lonza Biologics (UK and USA).

Her experience covers all aspects of the validation lifecycle in pharmaceutical manufacturing, QA laboratory and clinical trials management settings. As a Principle Consultant at ABB Life Sciences in Billingham, with responsibility for a team of five validation specialists, she scoped and delivered projects covering a wide range of pharmaceutical manufacturing, laboratory, clinical trials, and R&D systems. This included carrying out supplier audits on behalf of clients including audits at SAP and IBM (provision of hosting services). She also worked at ABB Headquarters on the implementation of Sarbanes-Oxley (SOX 404) IT infrastructure controls for financial systems for ABB Group, gaining knowledge of IT infrastructure and IS services regulatory requirements and methodologies such as COSO, COBIT and ITIL.

Examples of Jennifer’s computer systems validation (CSV) experience include the design and delivery of CSV and regulatory compliance training, the provision of consultancy, audits, gap analyses, GxP risk assessments, 21 CFR Part 11 and data integrity and project delivery across the full validation life-cycle, including, validation planning and reporting, design reviews, code reviews, planning and developing test protocols and ”use case” scenarios for performance testing. Her experience also includes working with clients to develop and implement quality management systems, policies and procedures, change management and electronic records and electronic signatures programmes as well as developing polices and best practice guidance for business continuity planning, system cut-over, testing approaches, data migration and system retirement.

While at ABB, Jennifer played a key role in establishing ABB’s Process Analytical Technology offer, working with ABB Bomem process analysers and ABB Automation systems experts. She carried out an analysis of the opportunities for the adoption of Process Analytical Technology in the biopharmaceutical manufacturing sector in Ireland, on behalf of Enterprise Ireland and provided regulatory compliance support on a subsequent £2m Euro pilot project on Process Analytical Technology in the biopharmaceutical sector involving ABB Ireland, University partners and manufacturers, funded by Enterprise Ireland. Jennifer has been an active member of the International Society of Pharmaceutical Engineers for many years and contributed to the GAMP® Good Practice Guide “A risk-based approach to GxP Process Control Systems” and the “ Risk-based Compliance Handbook” with Siegfried Schmitt published by the PDA.

A PhD physicist by training, Jennifer has also worked in the University sector at both Durham University and Teesside University developing highly successful business-academic partnerships, for example with IBM, P&G and others, leading to significant R&D and innovation funding awards. She has a keen interest in modelling and simulation and AI/Machine learning and their application in the pharmaceutical and healthcare sectors.

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