BIMO / GCP Auditor – Mock FDA Audit (Onsite - Dallas, TX) Contract

Pharmavise Corporation•Dallas, TX

14h•Onsite

About The Position

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.

Requirements

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

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