BIMO​/GCP Auditor – Mock FDA Audit; Onsite - Dallas, TX

Quick Summary

We are seeking an experienced BIMO / GCP Auditor to conduct an independent mock FDA BIMO audit in preparation for an upcoming NDA submission. This short-term engagement involves simulating an FDA inspection under IND regulations, assessing GCP compliance, and providing real-time feedback to identify gaps and inspection risks. The auditor will operate in a front-room / back-room FDA-style audit environment and deliver daily readouts to support timely remediation planning.

• Conduct an independent, GCP-scoped mock FDA BIMO audit for a drug-device combination product operating under an IND
• Simulate FDA inspection activities, including document requests, interviews, and system/process walkthroughs
• Evaluate compliance with FDA BIMO and ICH-GCP requirements, including:
  • Investigator oversight
  • Informed consent processes
  • Protocol adherence and deviations
  • Safety reporting and AE/SAE handling
  • Data integrity and documentation practices
  • Vendor and CRO oversight
• Operate within a front-room / back-room audit model to closely mirror an FDA inspection
• Provide daily audit readouts to client leadership and study teams, clearly explaining:
  • Identified gaps and inspection risks
  • Potential FDA observations vs. critical findings
  • Areas requiring remediation or corrective action
• Maintain an objective, inspection-ready demeanor consistent with FDA audit expectations
• Prepare a summary of audit observations and recommendations at the conclusion of the engagement

• 10+ years of experience in GCP auditing, clinical quality, or regulatory compliance
• Direct experience with FDA BIMO audits or inspections, either:
  • As a former FDA inspector, or
  • As an industry auditor supporting FDA BIMO inspections
• Demonstrated experience auditing clinical trials under INDs, preferably supporting NDA readiness
• Strong working knowledge of:
  • FDA BIMO regulations
  • ICH E6 (R2/R3) GCP guidelines
• Ability to independently lead audits and communicate findings clearly to cross-functional teams
• Excellent verbal and written communication skills, including delivery of real-time audit feedback
• Comfortable working in a fast-paced, inspection-style environment

• Engagement Type:
  Short-term consulting / contract
• Audit Dates:
  February 24–26 (with potential flexibility on adjacent days if needed)
• Location:
  
  On-site in Dallas, TX
• Working Hours:
  
  Approximately 8:00 AM – 5:00 PM, Monday–Friday
• Travel:
  Travel and lodging to be arranged per contract
• Remediation Support:
  Not in scope initially; potential follow-on support depending on audit outcome