Kyowa Kirin, Inc.- U.S. · 8 hours ago
Associate Director, Clinical Quality Management
Princeton, NJ
Full-time
Hybrid
Lead/Staff, Director/Executive
$190K/yr - $205K/yr
10+ years expKyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management Lead for Clinical Operations, responsible for proactive risk management across clinical trials and ensuring compliance with regulatory expectations.
Pharmaceuticals
Responsibilities
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
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: Known and emerging risks, Root causes, Mitigation strategies, Effectiveness of controls, Lead lessons learned activities across trials, audits, inspections, and CAPAs
Ensure lessons learned are: Systematically captured, Analyzed for trends, Fed back into RBQM planning, SOPs, training, and future studies, Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls
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, 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
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
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
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
Qualification
Required
Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required)
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
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)
Preferred
Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred)
Exposure to AI or predictive analytics for quality monitoring (preferred)
Benefits
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
Company
Kyowa Kirin, Inc.- U.S.
Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines.
501-1000 employees
H1B Sponsorship
Kyowa Kirin, Inc.- U.S. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (1)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Ana Bastiani-Posner, MBA
Executive Vice President & Chief Financial Officer
Tara D'Orsi
Executive Vice President, Chief Compliance Officer and General Counsel at Kyowa Kirin North America
Recent News
Business Journals
2024-03-08
2024-03-03
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