Associate Director, Clinical Quality Management

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions. The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations. Essential Functions: Risk-Based Quality Management (RBQM) Leadership•    Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance.•    Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors.•    Integrate RBQM principles into study planning, execution, oversight, and close-out activities.•    Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy. Central Risk Identification, Monitoring & Mitigation •    Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks.•    Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials.•    Oversee centralized risk monitoring and trending to enable early detection of critical risks.•    Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons  Learned & Risk Library Management (Core Ownership) •    Establish and maintain a centralized Clinical Risk Library, capturing:o    Known and emerging riskso    Root causeso    Mitigation strategieso    Effectiveness of controls•    Lead lessons learned activities across trials, audits, inspections, and CAPAs.•    Ensure lessons learned are:o &...