Simon Gillis

Senior Computer Systems Validation (CSV) and Quality Consultant with over 25 years’ experience delivering compliant, inspection-ready manufacturing and enterprise systems within regulated life sciences environments. Specialist in GxP, Annex 11, 21 CFR Part 11, GAMP 5 (R2), and ALCOA+ data integrity, with extensive expertise across MES, SAP, DCS/SCADA, LIMS, and eQMS platforms. Proven leader in validation lifecycle management, including URS, risk assessment (FRA/FMEA), IQ/OQ/PQ, remediation, and global audit support.

Highly experienced in Quality Management System (QMS) design and implementation, including the development of regulatory-aligned policies, SOPs, work instructions, and lifecycle governance frameworks. Director-level consultant with a strong background in integrating manufacturing systems with enterprise architectures, strengthening compliance maturity, and leading regulator-facing quality programmes. Currently expanding capability in AI governance and AI-enabled quality systems, combining deep compliance expertise with emerging digital transformation to support Pharma 4.0 and data-driven regulated operations.

• Senior Project and Quality consultant/manager with 25+ years working experience of Computer Systems Project Delivery, Validation and IT/OT Compliance in the life science industry.
• Wide range of experience in the proactive implementation and retrospective remediation projects at local and global levels for leading Life-Science companies
• Expert in project and quality management delivery for GxP and SOX systems used in life sciences
• Specific experience in Manufacturing and Laboratory systems as well as support systems such as MES/DCS/eQMS/LIMS
• Background in performing and hosting/supporting internal/external and regulatory audits
• Fully conversant with current regulations and industry best practices such as 21CFR Part 11, Annex 11, ISO13485 and GAMP
• Extensive experience in the validation of SaaS and cloud-based systems, platforms and infrastructure used in Manufacturing, Laboratory and support systems
• Fully conversant with information security practices related to on-premise, virtualized and cloud-based solutions and how they apply to the life sciences industry.
• The ability to work independently as well as to lead or be part of a team

MBA AI - Currently undertaking this and on target for a distinction level grading

Level 3 Software Engineering

HND Electrical and Electronic Engineering