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