Client Facing

GXP Quality Consultant

Our client launched a First-in-Human (FIH) study last July that is going well.  It is a small molecule Alzheimer’s program. In support of that they need to continue to build/update their Quality Management System (QMS) and stay on top of their audit plan.


  • Maintenance of Quality Management System documents including policies, standard operating procedures and the Quality Manual
  • Creating and overseeing the execution of the audit plan across GLP, GMP and GCP functions
  • Review of CDMO/CRO documents where Quality oversight is required (but not necessarily be the signatory approver)
  • Leadership of the Quality Committee including leading the investigation of any significant quality events and the execution of appropriate corrective and preventive actions (CAPA) as required.


  • Needs a true GxP person. (They are an N of one)


  • 9 months+ contract
  • ~20 hours/week
  • ASAP Start

Interested parties please send your CV and cover letter, or summary of your experience by clicking the link below.

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