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:
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Help build a comprehensive risk-based GCP compliance program
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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
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Ensure Clinical Operations, Development, Regulatory Affairs, and Medical Affairs activities are in compliance
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Support any company, vendor, and investigator site regulatory inspections and third-party audits as needed
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Act as SME during global regulatory agency inspections and third-party audits of vendors and investigator sites
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Support risk mitigation and continuous improvement initiatives
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Develop and maintain/refine SOPs
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Manage vendor qualification and GxP Vendor List
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Document record review
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Perform trend analysis/metrics of audit findings and provide summary reports to management of audit activities
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Implement and evaluate CAPAs
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Participate in GxP Compliance in activities overlapping with GLP, GVP, and GMP/GDP Compliance
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Assist in setting annual GCP audit schedule and preparing necessary budget
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All other duties as required
Qualifications:
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Scientific degree (B.S. or higher)
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ASQ – SQA certification
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5+ years of GCP auditing in the pharmaceutical industry
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Understanding of global GCP compliance regulations
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International auditing experience
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Experience with GCP CAPAs, trending analysis, and risk management
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Background using MasterControl, Trackwise Digital, Smartsheet, Veeva, eTMF, EDC, IVRS, etc
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Ability to travel up to 50% domestically/internationally