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GCP Auditor

Mackenzie Stuart is working in close partnership with a fast-growth Clinical Research Organisation with extensive clinical trial experience and operational excellence in a wide range of therapeutic areas.

Our client is actively recruiting a GCP Auditor – US based. This individual will be responsible for conducting audits and providing quality solutions to both internal and external customers whilst building and maintaining effective working relationships throughout the company.


  • Travel locally and across North America locations where sites are located as needed.
  • Maintain knowledge of ICH GCP principles
  • Lead/assist audit activities, inc. investigator site, key document, and sponsor audits
  • Follow audit activities from plan to closure
  • Support regulatory inspections onsite or remotely
  • Maintain quality tracking documents
  • Train new staff as required
  • Provide presentations on GCP topics, quality trends, continuous improvement activities
  • Assist with oversight of contract auditor assignments


  • Knowledge of ICH Good Clinical Practice guidelines
  • Understanding of clinical research regulations
  • Minimum of 3 years’ experience as GCP Auditor in Clinical QA
  • BS/BA Scientific/Healthcare related field
  • Experience of risk identification and employment of mitigation strategies
  • Required certification preferable; (SQA RQAP-GCP, ASQ Certified Quality Auditor)
  • Excellent interpersonal communication skills
  • Knowledge with GCPs and international and local regulations related to clinical trials
  • Ability to work independently and as a team
  • Practical ability in applying proactive quality approaches for clinical trials
  • Experience with clinical study/quality electronic systems

About Mackenzie Stuart Global Executive Search & Selection:
Mackenzie Stuart is a leading executive search and selection business. From our offices in Leeds, London & Toronto we provide retained and contingency recruitment solutions across industry and have specialist recruitment consultants that work within the Oil & Gas, Mining, Infrastructure & Built Environment, Medical & Scientific, Healthcare, Education, Finance & Accountancy, Insurance, Water, Chemicals & Coatings, Ingredients & Flavours, Automation, FMCG and Logistics sectors.

Job Reference: GCP QA//MM

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Salary Range

$80,000 - 120,000


United States