Global Quality Lead Auditior

Job Ref: J24501
Sector: Clinical
Sub-sector: Biotech/Life Sciences
Date Added: 27 November 2017
  • Berkshire, England, UK
  • Competitive
  • Gary Montgomery
  • 0203 096 4700

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Partnering with Non-Clinical Development in facilitating the quality mind-set into the preclinical portfolio across our clients sites. This position will support operations related to local and international development of new drugs and/or new indications.

Providing direct compliance and investigative support to areas of research operations which are within the scope of the Good Laboratory Practice (GLP) Compliance Programme, and the Good Clinical Practice (Laboratory) Guidelines (GCP Lab).

Main Responsibility

  • Supporting business partners to assess the capabilities of potential vendors of non-clinical and ancillary services in GLP and GCP Laboratory activities at the local/global level.
  • Actively ensuring multi-site study obligations including the Sponsor QA roles and responsibilities are met.
  • Assisting in the management and development, maintenance and execution of a robust QA Programme to ensure ongoing GLP and GCP Lab compliance, and robust safety data in support of our the client products
  • Partnering on the development and implementation of Good Research Practice principles and partner with Discovery Research to create ongoing training and awareness for the research teams on the importance of patent and intellectual property protection.
  • Reporting ongoing status of the non-clinical programmes relative to quality risks and outcomes.
  • Actively participating in generation of a summary/analysis of compliance and data integrity issues that have been observed for the QA programme activities, for upper management.
  • Developing and maintaining cooperative relationships with new and existing business partners.

Qualifications and experiences

  • You will need be a seasoned QA professional with a robust knowledge and understanding of the UK, EU and FDA regulations (GLP), as well as the UK/EMA GCP Laboratory Guidelines.
  • Additionally, you will be able to demonstrate the necessary attributes and behaviours for working with research scientists when discussing quality matters, to the extent that they are able to develop a trusting working relationship with you.
  • As a valued member of our small team, you will be flexible and adaptable, have a capability of leading and motivating projects with interdepartmental teams. Innovative problem solving skills are essential. You must have proven ability to use your excellent interpersonal and communication skills to positively influence outcomes.
  • You will be a graduate in a life science, ideally with a further Master's degree qualification.
  • The ability to travel internationally is essential

Please contact Gary Montgomery Via email at or can call me 07789878300 on if you would like to know more about this opportunity. Unfortunately, I cannot consider candidates outside the EU

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The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.