Senior GCP Auditor (remote/travel)

Our client has several FDA approved, commercially available therapies on the market for life-threatening diseases, and they’re always expanding the pipeline!

They are looking for a Senior GCP Auditor who can be based anywhere in the US (travel-ready!).

Key Duties:

  • Help build a comprehensive risk-based GCP compliance program

  • Conduct audits with remit across GCP activities covering qualification & routine evaluations of vendors/supplies, routine audits of Clinical Investigator sites, and internal process & function audits

  • Ensure Clinical Operations, Development, Regulatory Affairs, and Medical Affairs activities are in compliance

  • Support any company, vendor, and investigator site regulatory inspections and third-party audits as needed

  • Act as SME during global regulatory agency inspections and third-party audits of vendors and investigator sites

  • Support risk mitigation and continuous improvement initiatives 

  • Develop and maintain/refine SOPs 

  • Manage vendor qualification and GxP Vendor List 

  • Document record review

  • Perform trend analysis/metrics of audit findings and provide summary reports to management of audit activities

  • Implement and evaluate CAPAs

  • Participate in GxP Compliance in activities overlapping with GLP, GVP, and GMP/GDP Compliance

  • Assist in setting annual GCP audit schedule and preparing necessary budget

  • All other duties as required


  • Scientific degree (B.S. or higher) 

  • ASQ – SQA certification

  • 5+ years of GCP auditing in the pharmaceutical industry

  • Understanding of global GCP compliance regulations

  • International auditing experience 

  • Experience with GCP CAPAs, trending analysis, and risk management

  • Background using MasterControl, Trackwise Digital, Smartsheet, Veeva, eTMF, EDC, IVRS, etc

  • Ability to travel up to 50% domestically/internationally