Simon Gillis

CSV and AI Consultant - Life Sciences/GxP

Pharmaceutical / Bio-tech

Ashbourne, Derbyshire Dales District, Derbyshire

Services offered

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.

Computer systems validation

Gxp consultant

Ai consultant

Quality consultant

Approximate rate: £ 80 per hour

Experience

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