Associate Director, Clinical Quality Management

Associate Director, Clinical Quality Management

Princeton, New Jersey

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 risks

o Root causes

o Mitigation strategies

o Effectiveness of controls

Lead lessons learned activities across trials, audits, inspections, and CAPAs.

Ensure lessons learned are:

o Systematically captured

o Analyzed for trends

o 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:

o Risk-based inspection preparation

o Impact assessments

o CAPA development and effectiveness checks

Vendor & CRO Risk Oversight

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 Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance.

Provide RBQM training and coaching to study teams and cross-functional stakeholders.

Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics.

Participate as an observing member on assigned study teams to provide real-time quality and risk support.

SOP Management & Governance Support

Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates.

Support governance activities, senior management reporting, and quality metrics standardization.

Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.

Requirements:

Education

Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required)

Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred)

Experience

10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM

Demonstrated experience leading enterprise or cross-study risk management frameworks

Strong background in audit/inspection readiness, CAPA management, and vendor oversight

Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements

Technical Skills

Expertise with RBQM tools, centralized monitoring systems, and risk analytics

Experience defining and using KRIs, QTLs, and quality metrics

Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI)

Exposure to AI or predictive analytics for quality monitoring (preferred)

Working Conditions:

Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines.

The anticipated salary for this position will be $175,000 to $190,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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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