Senior CAPA FDA Lead

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