FDA Inspection Readiness Food Safety Compliance Consultant

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

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.

• 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.

• 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.

• Former FDA inspection or regulatory experience,…