Senior CAPA FDA Lead

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.

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