FDA Inspection Readiness Consultant - Food Safety (Remote)

The FDA Group; Boston (MA); Remote; USD 73,000 - 136,000; Full time

Job summary

The FDA Group is seeking an experienced consultant to support a food ingredient manufacturer preparing for its first U.S. FDA facility inspection.

You will conduct regulatory gap assessments, review SQF and HACCP systems, and help strengthen inspection readiness with practical, risk-based recommendations. Remote with potential onsite support, you will work with facility leadership to prioritize gaps, develop remediation plans, and guide personnel in preparing for FDA inspections.

Qualifications

• Demonstrated experience with FDA inspections, readiness, or regulatory assessments in food manufacturing.
• Strong working knowledge of U.S. FDA food safety regulations and inspection expectations.
• Knowledge of 21 CFR Part 117, CGMP and preventive controls for human food.
• Experience evaluating food safety management systems, HACCP, hazard analyses, and supporting documentation.
• Ability to assess operations, facility conditions, and documentation against FDA requirements.
• Experience identifying gaps and providing practical, risk-based corrective actions.

Responsibilities

• Conduct FDA inspection readiness and regulatory gap assessments for a food ingredient facility.
• Evaluate SQF-based quality systems, HACCP, hazard analyses, and preventive controls against FDA requirements.
• Review documentation for completeness, organization, and accessibility.
• Assess manufacturing procedures, records, sanitation, and supporting documents for FDA alignment.
• Identify gaps between SQF and FDA expectations and propose remedies.

Skills

FDA inspections

Regulatory compliance

CGMP knowledge

HACCP knowledge

Document review

Communication skills

Job description

The FDA Group is seeking an experienced consultant to support a food ingredient manufacturer preparing for its first U.S. FDA facility inspection.

You will conduct regulatory gap assessments, review SQF and HACCP systems, and help strengthen inspection readiness with practical, risk-based recommendations. Remote with potential onsite support, you will work with facility leadership to prioritize gaps, develop remediation plans, and guide personnel in preparing for FDA inspections.