FDA Inspection Readiness & Front-Room Training Consultant

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Job Summary:

Our Client is preparing for an FDA inspection of its Quality Management System and is evaluating the readiness of personnel who may serve in front-room roles during an inspection.

The organization currently has a limited number of individuals with significant front-room experience and is re-establishing a qualified pool of personnel capable of supporting inspection activity across its sites.

Our Client wants to ensure front room personnel are capable of guiding the inspectors through the process and system and instilling credibility of process knowledge, system awareness, and management of the quality system. Personnel need the ability to narrate that story credibly and to appropriately direct an FDA investigator's line of inquiry. This is a soft-skills capability gap rather than a procedural knowledge gap.

Primary Responsibilities:

Front-Room Readiness Assessment & Coaching

Assessment and soft-skills coaching of personnel who may serve in front-room roles during an FDA inspection.

Activities:

Conduct and observe mock inspection interactions using realistic investigator behavior, questioning technique, and pressure.

Evaluate individual readiness for front-room roles against defined readiness criteria.

Coach personnel on investigator engagement — building rapport, reading investigator intent, and managing the interaction.

Coach narrative and storytelling skills: presenting the intent and history behind documentation rather than relying on the documents to speak for themselves.

Coach directional control — appropriately guiding an investigator toward relevant, well-supported areas of the quality system.

Coach listening and response discipline: answering only what is asked, managing pauses and silence, and avoiding volunteering unnecessary information.

Provide feedback on handling inspection nuances, including unexpected requests, escalating questioning, and ambiguous or leading questions.

Deliver individualized feedback to each participant, including specific strengths and development areas.

Confirm and document whether each individual is ready to represent the organization during an FDA inspection.

Debrief site leadership on aggregate readiness, capability gaps, and recommended next steps.

Inspection Documentation Package Review

Independent experienced review of inspection documentation and supporting objective evidence.

Activities:

Review observations and the supporting objective evidence assembled for each.

Confirm documentation alignment and accuracy across the package.

Confirm that the evidence provided substantiates the intended response and would withstand investigator challenge.

Identify misplaced, inconsistent, duplicated, or missing documentation.

Assess whether the package supports the narrative front-room personnel will be expected to present.

Provide written feedback with prioritized recommendations for remediation of the package.

Anticipated locations include Pittsburgh, India, and additional Client sites to be confirmed.

Education/Work Experience/Requirements:

• Former FDA investigator with Medical Devices
• Strong, current FDA inspection experience across medical device / QMS…