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 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 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 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 .

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 real-time quality and risk support.

Requirements:

Education
Bachelors 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$190000 to $ 205000. 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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