What are the responsibilities and job description for the Senior CAPA FDA Lead position at Katalyst CRO?
Job Description
Key Responsibilities
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.
- 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.
- 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.
- 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