Pharmavise Corporation · 1 day ago
BIMO / GCP Auditor – Mock FDA Audit (Onsite - Dallas, TX) Contract
Dallas, TX
Contract
Onsite
Senior Level, Lead/Staff
10+ years expPharmavise Corporation is seeking an experienced BIMO / GCP Auditor to conduct an independent mock FDA BIMO audit in preparation for an upcoming NDA submission. The role involves simulating an FDA inspection under IND regulations, assessing GCP compliance, and providing real-time feedback to identify gaps and inspection risks.
Food and BeverageHealth Care
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
Qualification
Required
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
Strong working knowledge of 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
Company
Pharmavise Corporation
♦𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐮𝐚𝐥𝐢𝐭𝐲♦: 𝐏𝐡𝐚𝐫𝐦𝐚𝐯𝐢𝐬𝐞, 𝐲𝐨𝐮𝐫 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬, 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐆𝐨𝐯𝐞𝐫𝐧𝐦𝐞𝐧𝐭 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐩𝐚𝐫𝐭𝐧𝐞𝐫.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2020-04-04Seed
Leadership Team
Ricardo Joseph
Founder and CEO
Company data provided by crunchbase