• Successfully supported a multi national company to develop and implement a sustainable IS internal controls framework for ABB to satisfy their SOX and security requirements.• 8 years experience in delivering computer systems validation projects for both the pharmaceutical and biotech industries covering the complete validation life cycle from requirements gathering through to testing.• Knowledge of GxP, GAMP and FDA 21 CFR Part 11 electronic record and signatures requirements and ITIL IS/IT service delivery and support framework plus GDPR. Experience of Sarbanes-Oxley (SOX) 302 & 404 requirements for ITGC and their testing.• Development and delivery of training materials for a variety of validation methodologies and IS/IT technologies.• Multidiscipline Project Manager / Team Leader with a strong commitment to building cohesive and productive project teams.• Hands-on technical background in application software, database, operating systems, computer hardware, client/server, networks development and support. Familiar with the Microsoft product base; MCSE accredited also design and development of Internet/Intranet applications using Web-based products.• Experienced in advising Senior Management on business implications of technologies to achieve financial and regulatory goals; instructing end users and effectively monitoring emerging technologies.Specialties: GDPR for IS, COBIT, IS compliance, IS goverance processes, Sarbanes Oxley (SOX) and FDA IT compliance (21 cfr part 11 etc).