Dr Mandy Cooke FRSC is a GxP quality and compliance consultant specialising in building fit-for-purpose quality management systems for early-stage biotechnology and pharmaceutical companies, and ISO 13485-compliant QMS for medical device organisations. She founded Compliance-Science Ltd in January 2024 following a 30-year career in the pharmaceutical industry, including 15 years as a Senior Director at GSK where she led global QMS transformation programmes.

 

Mandy's work is defined by pragmatism and specificity. She translates complex FDA, EMA, MHRA, ICH and ISO requirements into streamlined, phase-appropriate systems that enable regulatory compliance without creating unnecessary operational burden — and that scale as organisations grow.

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Recent Consulting Engagements​

• QMS Design for Early-Stage Biotech —Designed and implemented comprehensive, phase-appropriate quality management systems for early-stage biotechnology companies and clinical CROs progressing through clinical development. Deliverables included document control hierarchies, change management and CAPA systems, training frameworks, and quality oversight governance — all aligned with ICH Q10 principles.

• GMP Audit Leadership —  Designed and executed  GMP audit programmes for major contract manufacturing organisations, including a sterile ophthalmic manufacturing facility in Bangladesh and a monoclonal antibody production site in Switzerland. Assessments covered EU GMP Annex 1 Contamination Control Strategies, aseptic process validation, environmental monitoring, and quality risk management.

• Pre-Approval Inspection Preparation — Prepared mock FDA Pre-Approval Inspection materials and interview programmes for client manufacturing sites, including biological licence application (BLA) submissions. Delivered senior leadership training sessions on GMP expectations and inspection readiness.

• Regulatory Training Design & Delivery —Designed and delivered bespoke training programmes on ICH E6(R3) for clinical operations teams, covering quality system implications, GMP/GCP interface requirements, and protocol risk assessment methodologies. Conducted regulatory compliance reviews of clinical protocols and quality management procedures.

• QMS Restructuring & Modernisation —  Led comprehensive restructuring of an established quality management system for a consumer health organisation, rationalising the document hierarchy, eliminating redundancy, and implementing risk-based approaches — resulting in improved operational efficiency and enhanced regulatory readiness.

• Quality Improvement Programme (QIP) Leadership — Leading structured quality improvement initiatives for clients requiring systematic gap remediation and inspection readiness recovery, providing programme governance, CAPA oversight, and stakeholder reporting.

• Medical Device Regulatory & QMS Framework — Developed the regulatory strategy and QMS compliance framework for a medical device company targeting UK market entry. Deliverables included a structured ISO 13485 requirements register, EU MDR Annex A framework, and statutory analysis of UK MDR 2002 obligations, providing the organisation with a clear roadmap for MHRA-compliant implementation.

 

Background & Expertise

Prior to founding Compliance-Science, Mandy spent 15 years at GSK in senior leadership roles spanning QMS strategy, global product quality, and regulatory affairs. As Senior Director and Global Head of QMS, she was accountable for the structure, governance, and delivery of GSK's enterprise-wide Quality Management System — a framework spanning GxP activities across development, manufacturing, and distribution globally. She previously led a five-year cross-business QMS transformation programme, the quality outputs of which were recognised as best practice by the British Quality Foundation.

 

Earlier in her career, Mandy spent a decade as founder and director of PharmaSolve Consultancy Ltd, delivering regulatory affairs and development management support across multiple therapeutic areas, including complex pan-European Marketing Authorisation applications. She also held leadership roles in regulatory affairs, project management, clinical research, and development management across a number of pharmaceutical companies.