Quality Management

Effective Quality Management Systems should ensure compliance while remaining practical, proportionate and fit for the organisation.
I have extensive experience in establishing, implementing, improving and standardising Quality Management Systems and quality processes in regulated life science environments.
My experience includes both strategic and hands-on work across Quality, Operations and R&D, and I support organisations in developing solutions that are compliant, effective and workable in practice.

Areas of Experience

• • Quality Management System
  • Supplier Quality Management
  • Deviations, CAPA & Systematic Problem Solving
  • Change Control
  • Risk Management
  • Process Validation
  • Software Validation
  • Training and Onboarding
  • Process Improvement and Optimisation
  • Harmonisation and Standardisation

I have worked with organisations of different sizes and levels of maturity and am used to adapting the approach to the specific organisation, product, regulatory requirements and business context. My focus is on creating solutions that support compliance without unnecessary complexity and that can be applied effectively in day-to-day operations.

If you would like to discuss a Quality Management challenge or a potential assignment, you are welcome to contact me.