FDA CAPA & Audit Lead — Regulatory Readiness

Katalyst CRO is seeking a senior regulatory/compliance professional to lead FDA audit readiness and interface with regulators. You will own CAPA, investigations, risk assessments, and HHE processes across the organization, ensuring robust, defensible responses during inspections. The role requires extensive experience in regulated industries, strong cross-functional leadership, and the ability to mentor teams on FDA expectations and documentation standards in a high-pressure environment.