Associate Director, RBQM Data Enablement and Analytics

Role: Senior Risk-Based Quality Management (RBQM) Data Enablement Lead responsible for configuring and optimizing RBQM platforms, including DQA, QTLs, and KRIs, to monitor clinical study risks and ensure compliance. Responsibilities: translate study risk assessments into system specifications, lead process improvements, act as a subject matter expert on RBQM methodology, manage data flows and platform operations, develop training materials, and oversee vendor and partner collaborations. Qualifications: minimum 8 years in pharma/CRO industry with at least 3 years in RBQM, plus 2 years managerial experience. Knowledge of regulations such as 21 CFR Part 11, ICH GCP standards; experience with risk management, audits, and data analytics systems required. High-Value: expertise in risk-based quality management within clinical trials, familiarity with GxP, data systems, and cross-functional leadership. Location: remote Massachusetts; full-time, exempt role.