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 Clinical Operations.
* Supports and ensures compliance with governance; participates in project team meetings and discussions, as needed.
* Recommend and implement remediation and corrective actions to ensure the integrity of Kyowa Kirin's systems, processes, and clinical documentation are maintained in accordance with corporate and regulatory directives.

Requirements:

Education
Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or closely related discipline. Advanced degree (e.g., Master's, PhD) in Clinical Research, Regulatory Affairs, Quality Management, or Data Science preferred.

Experience
* Minimum 10 years of clinical operations, clinical quality, or risk-based monitoring within the pharmaceutical, biotech or CRO industry.
* Strong experience in risk-based quality management (RBQM) and risk-based monitoring (RBM) methodologies.
* Expertise in ICH-GCP, FDA, EMA, and global regulatory requirements for clinical trials.
* Prior experience implementing risk management frameworks and working with quality management systems (QMS).
* Experience in audit/inspection readiness, CAPA management, and vendor oversight.
* Experience working at a Japanese based pharmaceutical plus.

Technical Skills
* Strong proficiency in RBQM tools and technologies, such as risk assessment platforms, centralized monitoring tools, or AI-driven analytics.
* Proven knowledge of clinical trial data analysis, statistical principles, and key risk indicators (KRIs)/quality tolerance limits (QTLs).
* In-depth experience working with clinical trial management systems (CTMS), electronic trial master file (eTMF) systems, and data visualization tools (e.g., Spotfire, Tableau, Power BI).
* Familiarity with machine learning
* Strong written, verbal, and presentation skills, with the ability to effectively communicate complex concepts to diverse audiences.
* Solid proficiency using Microsoft Office Suite including Word, Excel, and Power Point for documentation, analysis, and presentations.

Non-Technical Skills
* Highly motivated with great attention to detail.
* Strong problem-solving and critical-thinking abilities to proactively identify and mitigate risks.
* Excellent stakeholder management skills to collaborate across Clinical Operations, Quality, Regulatory, and Vendor teams.
* Ability to drive change and implement quality-focused cultural shifts within an organization.
* Strong leadership and project management skills to oversee RBQM initiatives and ensure alignment with business goals.
* Strong endurance to work under tight timelines and complex/changing situations.
* Work collaboratively in conjunction with the various operations teams to manage process Improvement Initiatives within timelines and budgets.
* Cultural sensitivity and ability to develop consensus within a multinational organization.

Working Conditions:

Requires up to 15% domestic and international travel

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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