💼 About This Role

You'll conduct a mock FDA Pre-Approval Inspection (PAI) at a client site in Indianapolis, assessing GCP and GMP compliance and readiness for regulatory inspections. Your core impact is identifying compliance gaps and risks to help the client avoid regulatory findings.

🎯 What You'll Do

• Conduct mock FDA Pre-Approval Inspection (PAI) to simulate regulatory scrutiny
• Evaluate compliance to GCP and 21 CFR 210/211 (GMP)
• Assess inspection readiness and documentation practices
• Identify compliance gaps and potential regulatory risks

📋 Requirements

• Direct experience supporting or hosting FDA inspections
• Experience conducting mock FDA inspections or PAI readiness assessments
• Strong experience auditing to GCP and 21 CFR 210/211
• Proven ability to conduct regulatory-style audits

✨ Nice to Have

• Background in clinical and commercial pharmaceutical environments
• Experience supporting high-visibility or regulatory-critical audits
• Located in the Midwest U.S.

📨 Hiring Process

Estimated timeline: 1-2 weeks · AI estimate

1. 1Phone Screen· 30 min
2. 2Technical Interview· 60 min
3. 3Offer· N/A