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