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

Dallas, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Apr, 26

Salary

0.0

Posted On

21 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GCP Auditing, Regulatory Compliance, FDA BIMO Regulations, ICH E6 GCP Guidelines, Clinical Trials, Audit Leadership, Communication Skills, Inspection-Style Environment, Document Requests, Interviews, System Walkthroughs, Safety Reporting, Data Integrity, Vendor Oversight, Corrective Action, Real-Time Feedback

Industry

Business Consulting and Services

Description

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 Requirements / Qualifications 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 Details: 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

Responsibilities

The auditor will conduct a mock FDA BIMO audit, simulating FDA inspection activities and evaluating compliance with relevant regulations. They will provide daily feedback to identify gaps and support remediation planning.