FDA Inspection Readiness Food Safety Compliance Consultant

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

FDA Inspection Readiness & Food Safety Compliance Consultant

Location: Ontario, Canada
Work Arrangement: Remote with potential onsite support
Start: As soon as possible

Position Overview

We are seeking an experienced FDA Inspection Readiness & Food Safety Compliance Consultant to support a food ingredient manufacturer preparing for its first U.S. FDA facility inspection.

The organization maintains an established food safety and quality management system supported by Safe Quality Food (SQF) certification, Hazard Analysis and Critical Control Points (HACCP), documented hazard analyses, and applicable food safety controls.

The consultant will conduct an FDA-focused regulatory gap assessment to evaluate existing documentation, manufacturing practices, facility conditions, and personnel readiness against applicable FDA requirements, including 21 CFR Part 117.

The primary objective is to identify potential compliance gaps, assess alignment between existing SQF-based controls and FDA expectations, and develop practical, risk-based recommendations to strengthen inspection readiness. The initial engagement will focus on assessment and preparation rather than a comprehensive mock FDA inspection.

Key Responsibilities

• Conduct an FDA inspection readiness and regulatory gap assessment for a food ingredient manufacturing operation.

• Evaluate existing food safety and quality systems against applicable FDA requirements, including 21 CFR Part 117.

• Review SQF-based quality systems, HACCP programs, hazard analyses, and preventive controls to identify potential regulatory gaps.

• Assess the completeness, organization, accessibility, and inspection readiness of quality and regulatory documentation.

• Review manufacturing procedures, production records, sanitation practices, and supporting documentation for alignment with FDA expectations.

• Evaluate facility conditions and operational controls from an FDA inspection readiness perspective.

• Identify differences between SQF certification requirements and applicable FDA regulatory expectations.

• Assess personnel preparedness for FDA inspector interactions, including document retrieval, inspection communication, and presentation of quality system records.

• Recommend improvements to documentation practices, records management, and inspection management procedures.

• Provide practical guidance to facility personnel and management on preparing for FDA inspections.

• Prioritize identified compliance gaps based on regulatory risk and potential inspection impact.

• Develop an actionable, prioritized remediation plan addressing identified deficiencies.

• Present assessment findings, regulatory risks, and recommended next steps to facility leadership.

Required Qualifications

• Demonstrated experience with FDA inspections, inspection readiness, or regulatory compliance assessments in food manufacturing environments.

• Strong working knowledge of U.S. FDA food safety regulations and inspection expectations.

• Knowledge of 21 CFR Part 117, including Current Good Manufacturing Practice (CGMP) and preventive controls requirements applicable to human food.

• Experience evaluating food safety management systems, HACCP programs, hazard analyses, and supporting quality documentation.

• Ability to assess manufacturing operations, facility conditions, and documentation against applicable FDA regulatory requirements.

• Experience identifying compliance gaps and developing practical, risk-based corrective action recommendations.

• Strong communication skills and ability to provide clear regulatory guidance to quality, operations, and facility leadership.

• Ability to independently conduct assessments and deliver actionable findings within a consulting engagement.

Preferred Qualifications

• Former FDA inspection or regulatory experience, particularly involving food manufacturing facilities.

• Experience conducting FDA inspection readiness assessments, mock inspections, or regulatory gap assessments.

• Familiarity with SQF certification requirements and their relationship to FDA food safety regulations.

• Experience supporting food ingredient manufacturers or business-to-business food manufacturing operations.

• Experience preparing facilities for their first FDA inspection.

• Familiarity with FDA expectations for inspection documentation, records management, and personnel interactions.

Work Arrangement

This engagement will initially focus on an FDA regulatory gap assessment and inspection readiness preparation.

Remote document review and virtual consultation are expected to support portions of the assessment, with potential onsite activities in Ontario, Canada, depending on facility needs and the agreed scope.

The consultant should be comfortable providing both strategic regulatory guidance and practical, actionable recommendations to improve facility inspection readiness.

Ideal Candidate

The ideal consultant is an experienced FDA food safety and regulatory compliance professional with strong knowledge of 21 CFR Part 117, food manufacturing operations, SQF/HACCP systems, and FDA inspection readiness. The individual should be capable of independently identifying regulatory gaps, translating FDA expectations into practical recommendations, and helping an established food manufacturing operation prepare effectively for its first FDA inspection.