Associate Director, Quality Risk Management

Lead Quality Risk Management activities across clinical programs, partnering with CORM, R&D QA, CAPA CoE, and Clinical Quality Assurance to embed Quality by Design and ensure end-to-end CtQ risk mitigation. Responsible for developing the Quality Narrative at study/TA level, identifying CtQ data and vendors, guiding risk mitigation, monitoring deviations and significant issues, and providing regulatory intelligence and coaching to trial teams. Ensure compliance with ICH/GCP and other regulations, support incidents and quality issues escalation, and lead cross-functional initiatives to drive quality improvements across regulatory and external engagements. Requires advanced degree in science/quality with 8+ years QA experience and strong communication, project management, and stakeholder management skills.