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.
• ct 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
• udit Presentation & Defense
• Quality Systems
• Cross-functional Leadership
• Executive Communication
