Kyowa Kirin North America
Associate Director, Clinical Quality Management
Princeton, New Jersey · Director
Sponsorship not specified$175k-$190kDetected 44 days ago
GCPData AnalysisData ScienceData VisualizationComplianceVendor ManagementRecruitingClinical TrialsClinical ResearchPublic HealthFDA RegulatoryResearchExperimental DesignLeadershipCollaborationMentoringBiostatisticsRegulatory Affairs
About the role
- 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.
- 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.
Responsibilities
- Lead lessons learned activities across trials, audits, inspections, and CAPAs.
Requirements
- 10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM
- Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements
Nice to have
- Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred)
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)
- 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.
- Oversee centralized risk monitoring and trending to enable early detection of critical risks.
- Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs.
- Provide centralized quality oversight across trials, CROs, and vendors.
- Monitor vendor performance using quality metrics and risk indicators.
- Ensure vendor-related risks are integrated into the central risk library and lessons learned framework.
Compensation
- The anticipated salary for this position will be $175,000 to $190,000.
Benefits
- 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
- Life & Disability Insurance
- Tuition Assistance
Company info
- In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
Visa & Work Authorization
- ability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law
Apply directly at Kyowa Kirin North America →Create a free account for alerts like thisView Kyowa Kirin North America immigration profile
This listing is sourced directly from Kyowa Kirin North America's careers page and normalized into a canonical job model.