BIMO / GCP Auditor – Mock FDA Audit (Onsite - Dallas, TX) Contract
contract•Dallas
About this 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
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 outcome
What you'll do
- 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.
About Pharmavise Corporation
♦𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐮𝐚𝐥𝐢𝐭𝐲♦: 𝐏𝐡𝐚𝐫𝐦𝐚𝐯𝐢𝐬𝐞, 𝐲𝐨𝐮𝐫 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬, 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐆𝐨𝐯𝐞𝐫𝐧𝐦𝐞𝐧𝐭 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐩𝐚𝐫𝐭𝐧𝐞𝐫.
𝗔𝗯𝗼𝘂𝘁 𝘂𝘀 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻:
We provide high-quality, cost-effective people and process solutions for your Quality, Regulatory, Engineering, Clinical, and Healthcare needs. Our company mantra 𝐄𝐗𝐂𝐄𝐋𝐋𝐄𝐍𝐂𝐄 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐔𝐀𝐋𝐈𝐓𝐘. The safety and quality of the drugs and devices produced for patients are directly related to 2 things, 𝐑𝐎𝐁𝐔𝐒𝐓 𝐏𝐑𝐎𝐂𝐄𝐒𝐒 𝐚𝐧𝐝 𝐐𝐔𝐀𝐋𝐈𝐅𝐈𝐄𝐃 𝐏𝐄𝐎𝐏𝐋𝐄. 𝐖𝐞 𝐝𝐞𝐥𝐢𝐯𝐞𝐫 𝐛𝐨𝐭𝐡.
𝐃𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐭𝐢𝐚𝐭𝐨𝐫𝐬:
☑𝐇𝐢𝐠𝐡𝐥𝐲 𝐒𝐤𝐢𝐥𝐥𝐞𝐝 𝐓𝐞𝐚𝐦: Our team of experienced consultants with distinct backgrounds in life sciences, including scientists, researchers, and regulatory experts. The quality and expertise of our team significantly impact our client’s success.
☑𝐒𝐩𝐞𝐜𝐢𝐚𝐥𝐢𝐳𝐞𝐝 𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞: We focus on specific niches within the life sciences, healthcare, and government sectors, such as pharmaceuticals, biotechnology, medical devices, regulatory affairs, medical research, and product development. This specialized expertise allows us to offer targeted and in-depth insights to our clients.
☑𝐂𝐮𝐬𝐭𝐨𝐦𝐢𝐳𝐞𝐝 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬: We offer tailored solutions that align with the specific requirements of each client, rather than one-size-fits-all approaches, demonstrating a commitment to meeting client needs. We do not require a long learning curve, which leads to a faster payback and a greater return on your investment.
𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗛𝗶𝘀𝘁𝗼𝗿𝘆
Over 20 Technical Transfers and 30 product launches.
11 FDA remediations. Warning Letters and or Consent Decrees.
Cost savings and increased efficiency of over 10MM for clients
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Frequently Asked Questions
What does a BIMO / GCP Auditor – Mock FDA Audit (Onsite - Dallas, TX) Contract do at Pharmavise Corporation?
As a BIMO / GCP Auditor – Mock FDA Audit (Onsite - Dallas, TX) Contract at Pharmavise Corporation, you will: 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..
Is the BIMO / GCP Auditor – Mock FDA Audit (Onsite - Dallas, TX) Contract position at Pharmavise Corporation remote?
The BIMO / GCP Auditor – Mock FDA Audit (Onsite - Dallas, TX) Contract position at Pharmavise Corporation is based in Dallas, Texas, United States. Contact the company through Clera for specific work arrangement details.
How do I apply for the BIMO / GCP Auditor – Mock FDA Audit (Onsite - Dallas, TX) Contract position at Pharmavise Corporation?
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