FDA CAPA & Audit Lead — Regulatory Readiness

Katalyst CRO; Bothell (WA); On-site; USD 180,000 - 240,000; Full time

Job summary

Katalyst CRO is seeking a senior regulatory/compliance professional to lead FDA audit readiness and interface with regulators. You will own CAPA, investigations, risk assessments, and HHE processes across the organization, ensuring robust, defensible responses during inspections.

The role requires extensive experience in regulated industries, strong cross-functional leadership, and the ability to mentor teams on FDA expectations and documentation standards in a high-pressure environment.

Qualifications

• 10+ years of experience in Quality, Compliance, Regulatory, or related functions within regulated industries.
• Hands-on CAPA management, root cause investigations, Health Hazard Evaluation (HHE), and FDA audit/inspection work.
• Proven ability to lead regulatory programs and present during FDA interactions.

Responsibilities

• Lead FDA audit and inspection readiness activities across the business.
• Own and present CAPA effectiveness, investigation quality, risk assessments, and HHE processes during FDA interactions.
• Act as the primary presenter/interface for FDA inspections, regulatory meetings, and compliance discussions.
• Review and strengthen CAPA systems to ensure regulatory compliance, effectiveness, and sustainability.
• Drive HHE assessments for product quality issues, complaints, deviations, recalls, and field actions.
• Coordinate with Quality, Regulatory Affairs, Manufacturing, Engineering, Supply Chain, and Leadership teams to ensure audit preparedness.
• Conduct gap assessments against FDA expectations and industry best practices.
• Support mock audits, inspection simulations, and response preparation activities.
• Ensure timely closure of audit observations, commitments, and remediation plans.
• Mentor teams on FDA expectations, documentation standards, root cause analysis, and inspection behavior.
• Support preparation and review of regulatory responses, including 483 responses and associated action plans.

Skills

FDA Inspection Readiness

CAPA Effectiveness

Health Hazard Evaluation

Root Cause Analysis

Regulatory Compliance

Audit Presentation

Risk Assessment

Quality Systems

Cross-functional Leadership

Executive Communication

Job description

Katalyst CRO is seeking a senior regulatory/compliance professional to lead FDA audit readiness and interface with regulators. You will own CAPA, investigations, risk assessments, and HHE processes across the organization, ensuring robust, defensible responses during inspections.

The role requires extensive experience in regulated industries, strong cross-functional leadership, and the ability to mentor teams on FDA expectations and documentation standards in a high-pressure environment.