GCP/GMP Auditor – Former FDA / FDA Inspection Experience (Midwest USA) in Indianapolis, Indiana at SQA Services

SQA Services is seeking a senior auditor with former FDA experience and direct FDA inspection exposure to support a 4-day mock FDA Pre-Approval Inspection (PAI) in Indianapolis, Indiana.

This engagement will simulate an FDA inspection environment, requiring an auditor who understands FDA expectations, inspection readiness, and compliance risks across GCP and GMP operations. The auditor will play a key role in assessing readiness and identifying gaps prior to a regulatory inspection.

Auditors located in the Midwest U.S. or willing to travel are preferred.

• Conduct a mock FDA Pre-Approval Inspection (PAI) in alignment with FDA expectations
• Evaluate compliance to Good Clinical Practices (GCP) and 21 CFR 210/211 (GMP)
• Assess inspection readiness, quality systems, and documentation practices
• Identify compliance gaps and potential regulatory risks
• Provide detailed audit findings and recommendations
• Prepare and deliver audit reports per client and SQA standards
• Communicate observations clearly to stakeholders and leadership

• Direct experience supporting/hosting FDA inspections
• Experience conducting mock FDA inspections or PAI readiness assessments
• Strong experience auditing to GCP and 21 CFR 210/211 (GMP)
• Proven ability to conduct regulatory-style audits (PAI readiness or mock FDA inspections)
• Strong understanding of FDA inspection processes and expectations
• Excellent reporting, communication, and stakeholder engagement skills
• Willingness to travel to Indianapolis, IN for a 4-day audit