Senior CAPA FDA Lead

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: o CAPA management systems o Root cause investigations o Health Hazard Evaluation (HHE) o FDA audit/inspection management o 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