Associate Director, Clinical Quality and Continuous Improvement

Associate Director, Clinical Quality and Continuous Improvement Overview Provides strategic QA oversight across clinical development procedures to ensure compliance with GCP requirements, regulatory expectations, and internal quality standards. Serves as the primary QA partner across clinical development activities by providing oversight of process adoption and compliance, contributing to operational process improvements, and leading enterprise and multi-study issue management. Ensures that quality events, audit and inspection learnings, and regulatory expectations are effectively incorporated into operational processes and study execution. Partners closely with stakeholders across Development, clinical study teams, and Quality teams to drive sustainable quality outcomes through metrics, trend analysis, and root cause analysis, strengthening process effectiveness, enhancing compliance, and enabling consistent issue management across studies. This position is open to remote working. Key Responsibilities 1. Process Improvement & Quality System Enhancement Represent QA in operational process improvement initiatives, influencing process design, execution, and compliance to ensure alignment with regulatory expectations, organizational strategy, and risk-based quality management principles. Identify process inefficiencies and implement scalable, standardized solutions to enhance quality system performance. Partner cross-functionally to embed quality into end-to-end processes. Provide input into change management strategy(ies) for new and heavily revised processes. Acts as a subject matter expert in driving scalable quality solutions within continuous improvement activities across clinical and, where applicable, pre-clinical (GLP) and post-market (PV) domains. 2. Process Adoption Monitoring & Compliance Assurance Establish and maintain mechanisms to measure process adoption, compliance, and effectiveness following implementation of new or revised processes. Lead targeted p