Associate Director, Clinical Quality Management
About The Position
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.
Requirements
- 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)
Nice To Haves
- Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred)
- Exposure to AI or predictive analytics for quality monitoring (preferred)
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
- 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.readiness.
- 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
- 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.
- Champion a culture of proactive quality and continuous improvement across Clinical Operations.
- 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.provide real-time quality and risk support.
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
