KH
Senior CAPA FDA Lead
Katalyst Healthcares & Life Sciences
🇺🇸 United States
Hybrid
Staff / Principal
4 months ago
- CAPA
- Regulatory Compliance
- GMP
- Risk Management
4 months ago
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
Senior CAPA FDA Lead · Katalyst Healthcares & Life Sciences