Associate Director, Risk Management

Role: Senior GCP Quality Risk Management Expert supporting clinical development in neurodegenerative diseases. Objectives: lead GCP deviation, CAPA, vendor qualification, and risk mitigation activities to ensure compliance and inspection readiness. Responsibilities: partner with study teams to identify and manage quality risks using QbD and RBQM principles; oversee deviation and CAPA processes; analyze compliance data to identify trends and drive continuous improvement; support regulatory inspections; contribute to QMS enhancements. Requirements: Bachelor's degree with 12+ years (or equivalent experience) in GCP QA; strong knowledge of ICH E6 GCP, GVP, FDA regulations; experience with QbD, RBQM, GxP environment; excellent analytical, communication, and cross-functional collaboration skills. Preferred: advanced degrees (Master's/PhD) and extensive experience in clinical GxP quality oversight. High-Value: focus on clinical trial quality assurance, risk management, vendor oversight, and inspection readiness within neurodegenerative disease programs. WorkSetup: not specified; likely office-based or hybrid based on standard industry practices.