Jobs at Kyowa Kirin

Lead vendor oversight and delivery of CDISC datasets, TLF shells and statistical programming for regulatory submissions. Manage vendor selection, timelines, budgets, and QC of deliverables. Provide SAS programming, review study documents, collaborate with biostatisticians and cross-regional teams, and support process improvements and FDA inspection readiness.

The Senior MSAT Engineer will provide technical leadership for mAb drug substance manufacturing and technology transfer, ensuring compliance and efficiency.

The Associate Director manages budget governance, forecasting, financial risk, and process optimization for clinical studies, ensuring financial integrity and compliance with standards.

Perform month-end close activities, prepare journal entries and reconciliations, analyze variances, produce quarterly financial packages, maintain internal controls, apply IFRS/US GAAP, improve accounting processes, and collaborate with cross-functional teams to support financial reporting and compliance.

This position is for candidates to express their interest in future job openings by joining the Kyowa Kirin Talent Community.

Lead adoption and enablement for Veeva CRM and Salesforce through training, documentation, communications, and user support. Partner with commercial stakeholders and IT to manage releases, UAT, metrics, and continuous improvement while ensuring compliance with policies and regulatory standards.

Support QA operations at a greenfield monoclonal antibody manufacturing site: perform shop-floor QA, batch record review and disposition, oversee warehouse/incoming quality, lead investigations and CAPAs in Veeva, monitor quality metrics, ensure data integrity (ALCOA+, 21 CFR Part 11), and participate in inspection readiness and continuous improvement.

The Specialist II in Quality Control Microbiology conducts microbiological testing, maintains compliance with GxP standards, and collaborates cross-functionally to support facility readiness in a biopharmaceutical setting.

Serve as the primary legal business partner for Kyowa Kirin's Sanford manufacturing site, providing support on contracts, regulatory, and operational matters while collaborating with various stakeholders.

Lead functional design, configuration, and optimization of Microsoft Dynamics 365 F&O across Finance, Supply Chain, Manufacturing, Procurement and Quality. Translate business requirements into scalable solutions, manage integrations, ensure GxP/SOX compliance, oversee implementations, validations, governance, vendor management, and stakeholder training.

The Quality Engineer Lead oversees quality and compliance for the startup of a new pharmaceutical site, ensuring regulatory readiness and driving process improvements. Responsibilities include problem-solving, documentation review, and cross-functional collaboration. Strong interpersonal skills are essential for fostering a supportive work environment.