Claire Glenister

Claire has worked within the pharma sector for the last 24 years.  The first 15 years of her career were spent working in a variety of roles for a global manufacturer. These roles included Quality Manager for both manufacturing and non-manufacturing areas of the business and, latterly, as the Site Compliance Auditor which involved undertaking regular audits of all areas related to the manufacturing and testing of respiratory and oral solid dose products.  This included the introduction of new products fed through from the Research and Development arm of the business.  She has significant experience in areas of manufacturing, particularly QMS implementation, Quality Assurance and project management .

In 2013, Claire joined the MHRA as a GDP inspector.  The role involved inspecting the full portfolio of UK WDA holders and respective business models, including challenging and non-compliant sites. She has an excellent understanding of how the EU GDP Guidelines and the HMR 2012 should be applied to a companies operations and specialises in the development of appropriate QMS’s for businesses.

Claire is also experienced in presenting to large audiences as part of her role in the MHRA when presenting at the annual symposia.  Along with Peter, she has also run well-received training sessions and workshops on QMS in GDP for the PIC/S programme with an international audience of regulatory inspectors.

Claire’s time with the agency covered the implementation of both the EU GDP Guidelines in 2013, the Falsified Medicines Directive in 2019 and the Covid-19 response in 2020. Claire became Operations Manager for GDP at the MHRA, responsible for her team and a number of business areas including the operational delivery of the inspection plan for the UK whilst still carrying out complex inspections of larger companies and sites. 

Claire holds the following professional qualifications and accolades:

  • Practitioner status with the Chartered Quality Institute (PCQI)

  • BSc (Hons) in Business Administration

  • MHRA GDP Inspector training course and certification

  • Quality Assurance Management Development Programme (internal to GSK)

  • ISO 9000:2000 trained

  • RSSL Auditor/Lead Auditor trained

  • GlaxoSmithKline Certified Auditor

  • PRINCE 2 Practitioner

  • City and Guilds  NVQ level 2 certificates in ‘Facilitating learning through individual coaching (C25) and ‘Conducting non competence based assessments’ (D21)

  • CQI module D1 – Quality Principles

  • CQI module D2 - Quality Management

  • CQI module D3 – Quality Tools and Techniques