GCP/GMP Auditor Former FDA / FDA Inspection Experience (Midwest USA)

For more than 30 years, SQA Services has been a leader in providing managed supplier quality services — including audits, assessments, corrective actions, inspections, remediation, and engineering support — to manufacturers across regulated industries. We deploy experienced auditors across the United States and in over 90 countries to support client and supplier sites on demand.

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.

Key Responsibilities

• 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

Required Qualifications

• D irect 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

Preferred Qualifications

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

4-day audit Pay Rate inclusive of preparation, travel, audit execution, reporting, and follow-up. Travel expenses reimbursed at cost with receipts per SQA travel policy. Note: SQA is an Equal Opportunity Employer. Employment is based on merit and qualifications, and is not influenced by race, color, religion, gender, national origin, veteran status, disability, age, sexual orientation, gender identity, marital status, or any other legally protected status. This position requires access to ITAR-controlled technical data and/or defense articles. As such, the candidate must be a U.S. citizen or U.S. lawful permanent resident (green card holder) to comply with the International Traffic in Arms Regulations (ITAR). Applicants who do not meet these criteria will not be considered for this role.