Senior CAPA FDA Lead

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

• 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 Health Hazard Evaluation (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 where applicable.

Job Description

Key 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 Health Hazard Evaluation (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 where applicable.

Required Experience

• 10
• years of experience in Quality, Compliance, Regulatory, or related functions within regulated industries such as Pharma, Medical Devices, Biotechnology, or Healthcare.
• Strong hands-on experience in:
• CAPA management systems
• Root cause investigations
• Health Hazard Evaluation (HHE)
• FDA audit/inspection management
• Regulatory compliance programs
• Prior experience leading or presenting during FDA inspections/audits with successful outcomes.
• Demonstrated experience handling regulatory escalations, observations, and remediation programs.
• Strong understanding of FDA regulations, GMP, QMS, risk management, and compliance expectations.
• Experience working in cross-functional and high-pressure audit environments.

Preferred Qualifications

• Experience handling FDA inspections involving critical observations or remediation programs.
• Exposure to recalls, field actions, complaint handling, and product risk evaluations.
• Certifications in Quality or Regulatory disciplines are preferred.
• Strong executive communication and stakeholder management skills.

Key Skills

• FDA Inspection Readiness
• CAPA Effectiveness
• Health Hazard Evaluation (HHE)
• Regulatory Compliance
• Root Cause Analysis
• Risk Assessment
• Audit Presentation & Defense
• Quality Systems
• Cross-functional Leadership
• Executive Communication