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 make people smile by delivering breakthroughs 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, Massachusetts, and Ontario.

Summary:

The Associate Director, Clinical Quality Management will serve as a Holistic Risk-Based Quality Management (RBQM) to Lead to develop and implement proactive risk management strategies within Clinical Operations. 

This role will oversee risk identification, mitigation, and compliance with regulatory requirements while ensuring data-driven decision-making and continuous quality improvement. Collaborate cross-functionally to enhance trial oversight, vendor management, and inspection readiness. Provides support with SOP Management, Inspection Readiness and CAPAs

Essential Functions:

Quality Risk Management:
Clinical Operations Risk-Based Quality Management (RBQM) Strategy & Implementation
o    Develop and implement a holistic RBQM framework aligned with ICH E6 (R3) and other regulatory requirements.
o    Establish risk identification, assessment, and mitigation processes across clinical operations.
o    Collaborate with cross-functional teams to integrate risk-based decision-making into study planning, execution, and oversight.
o    Provide oversight and support to study teams in development of risk-based quality management study level. 
 

Risk Identification, Monitoring, & Mitigation
o    Lead proactive risk assessments at department levels, and its impact to study level ensuring early detection of critical risks.
o    Lead proactive actions to mitigate risks including lessons learned awareness activities. 
o    Define Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) for effective risk monitoring.
o    Work with study teams to establish risk mitigation and contingency plans to ensure inspection readiness.

Quality Oversight & Compliance
o    Ensure clinical trial activities comply with GCP, regulatory requirements, and company SOPs.
o    Partner with Clinical Operation, relevant functions and Vendors to ensure continuous quality monitoring.
o    Support audit/inspection readiness and drive corrective and preventive action plans (CAPAs).

Vendor & CRO Risk Oversight
o    Implement risk-based oversight strategies for CROs and third-party vendors.
o    Monitor vendor performance against quality metrics and contractual obligations.
o    Lead quality governance discussions with external partners.

Data-Driven Decision Making & Continuous Improvement
o    Utilize data analytics and A-driven tools to drive real-time quality monitoring and risk mitigation.
o    Generate risk trend reports and insights to improve clinical trial execution.
o    Champion a culture of continuous improvement by refining RBQM methodologies based on lessons learned.

Cross-Functional Collaboration & Training
o    Provide RBQM training to Clinical Operations, Quality, and other stakeholders.
o    Collaborate with Regulatory, Biostatistics, and Data Science teams to ensure alignment of risk metrics.
o    Act as an RBQM subject matter expert (SME) for internal and external stakeholders.
o    Observing member as part of assigned trial’s study teams to assist and support in any quality related issue including liaising with appropriate department person or other function and if any risks need to be reported as appropriate to vendor governance, QA, issue escalation or senior management.
o    Providing guidance and assistance to study teams based on audit findings, ongoing CAPAs, and ongoing changes within Clinical Operations. 
o    Review of assigned trial’s Risk Based Quality Management plan and system in collaboration with the study teams.

SOP Management: 
•    Liaise and collaborate with Document Control and SOP Administration team as needed for SOP Management. 

All CQC Employees: 
•    Work with CQC colleagues and cross functionally, study team members and other stakeholders to ensure consistency with SOPs/WIs updates, lessons learned from trial to trial or region to region.  
•    Standardize, track, and report appropriate quality management and control metrics during Senior Management meetings and reports.  
•    Support inspection readiness activities within Clinical Quality Compliance and Clinic