Matt Barthel
Chief Technology Officer @Gxp Engaged
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WORK HISTORY
Chief Technology Officer @Gxp Engaged
Harrogate, GB
EDUCATION
Anglia Ruskin University
Diploma in Research Quality Assurance
Leeds Western School of Nursing, Health Visiting & Midwifery at Leeds General Infirmary
RN Training
BSI Training Academy
BSI Lead Auditor, ISO 9000 Lead Auditor
City & Guilds
Teaching - Adult and Further Education Teaching Certificate
SKILLS
ABOUT MATT BARTHEL
Quality Assurance professional with over 30 years\' experience, specialising in GCP, regulated computer systems compliance (validation, 21CFR11 compliance, InfoSec), digital/decentralized clinical trials (DCTs), design and implementation of Quality Management Systems (QMSs), Systems Development Life Cycles (SDLCs) and GDPR/global data privacy and integrity programmes. QA Consultant providing high-quality consultancy for Pharma, CRO and regulated system/SaaS developers. Chief Technology Officer and Data Protection Officer, responsible for GCP-regulated IT and Data Privacy compliance strategy and delivery, with a strong understanding of GDPR, InfoSec and global data privacy requirements. Extensive regulated computer system audit experience including SaaS, IRT, eCRF, eDMS, eTMF, eQMS, ePRO and eCOA. Specialist in the application of 21CFR11 and GAMP/Agile and CSA. Matt has an in-depth knowledge of GCP QA requirements in Phases I-IV, gained through progressively senior roles at Covance (now LabCorp), GSK, Quintiles (now IQVIA), AstraZeneca, PPD and ADAMAS Consulting (one of the largest and most-respected QA consultancies in the world) and is especially experienced in Phase I/Clinical Pharmacology. He has broad international audit experience, having led investigator site, computer systems compliance, project, vendor and process audits in Europe and the USA, Canada, South Africa, Russia, Turkey, Israel, India, China, Singapore and Japan. Matt is the former global head of Quintiles Early Clinical Development (Clinical Pharmacology), Global Central Lab (QLAB, now Q2 solutions) and Cardiac Safety Services QA groups, with over 40 reports in 9 countries. Matt has managed complex quality issues and varied regulatory inspections, including EMA, FDA, MPA, DGCI and MHRA as well as CLIA and UK Environment Agency and ISO9001, 13485, 27001, and 15189. He holds the RQA Diploma in Research QA, is a qualified trainer & ISO9001 Lead Auditor and is a former tutor on RQA training courses and the Cranfield University MSc in Quality Management in Scientific Research and Development.
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