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BIMO / GCP Auditor – Mock FDA Audit (Onsite - Dallas, TX) Contract
Pharmavise CorporationUnited StatescontractVerifiedPosted 21 Jan 2026
About the role
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.
Key Responsibilities
- 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
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