Simon Gillis

WORK HISTORY

ABOUT SIMON GILLIS

Strategic compliance and quality leader with over 25 years of experience delivering global GxP, CSV, CSA, and information security programmes across the life sciences sector. As Founder and Principal Consultant at IS Compliance Solutions Ltd, I provide expert consultancy in computer systems validation, data integrity, and project quality management to pharmaceutical, biotech, and SaaS organisations worldwide.My career spans hands-on delivery and leadership of large-scale IT/OT compliance initiatives, including the validation of manufacturing, laboratory, and support systems such as MES, DCS, LIMS, EDMS/EQMS, and cloud-based platforms. I’ve led remediation and transformation programmes for clients like Novartis, AstraZeneca, Oxford Nanopore Technologies, and Clarivate Analytics, managing everything from architectural integration to vendor assurance and regulatory audit readiness.I’m fully conversant with global regulations and standards including 21 CFR Part 11, Annex 11, ISO 13485, IEC 62304, GAMP5, and SOX. My technical proficiency spans secure architecture design, cloud validation, and information governance, supported by qualifications in CISA, PMP, PRINCE2, and an ongoing MSc/MBA in Artificial Intelligence. I bring a unique blend of strategic oversight and operational execution, having served as Global eCompliance Manager, Head of Information Governance, and Project Quality Lead across multiple international sites.Whether leading validation lifecycle activities (URS, VP, FRA, IQ, OQ, PQ, VR), designing QMS frameworks, or supporting regulatory audits, I deliver scalable, compliant solutions tailored to complex environments. I’m passionate about bridging practical experience with emerging technologies, contributing thought leadership to industry forums, and mentoring teams in best practices for digital transformation and compliance excellence.