Associate Director, Clinical Quality Management

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:

• 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 readiness.

• Learned & Risk Library Management (Core Ownership)
  • Establish and maintain a centralized Clinical Risk Library, capturing known and emerging risks, root causes, mitigation strategies, and effectiveness of controls.
  • Lead lessons learned activities across trials, audits, inspections, and CAPAs.
  • Ensure lessons learned are systematically captured, analyzed for trends, and fed back into RBQM planning, SOPs, training, and future studies.
  • Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.

• Quality Oversight & Regulatory Compliance
  • Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs.
  • Provide centralized quality oversight across trials, CROs, and vendors.
  • Support audit and inspection readiness activities, including risk-based inspection preparation, impact assessments, and CAPA development and effectiveness checks.
  • Design and implement risk-based oversight strategies for CROs and external vendors.
  • Monitor vendor performance using quality metrics and risk indicators.
  • Lead or support quality governance discussions with external partners.
  • Ensure vendor-related risks are integrated into the central risk library and lessons learned framework.

• Data-Driven Quality & Continuous Improvement
  • Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making.
  • Generate enterprise-level risk trend reports and insights for senior leadership.
  • Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned.
  • Champion a culture of proactive quality and continuous improvement across Clinical Operations.

• Cross-Functional Collaboration & RBQM Expertise
  • Act as the RBQM…