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The Senior Process Engineer will design, commission, and operate the manufacturing facility, focusing on process optimization, troubleshooting, and documentation support.

The role involves managing clinical samples for biomarker testing, coordinating with vendors, conducting data analysis, ensuring compliance, and contributing to clinical trial activities.

The Sr. Manager, CQV is responsible for leading commissioning, qualification, and validation efforts in pharmaceutical manufacturing, ensuring compliance with regulatory standards.

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

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

The Quality Engineer, FUME Lead ensures compliance during the startup of the Sanford site, overseeing Quality Engineering processes and regulatory readiness for facilities, utilities, and equipment.

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.

Manage R&D QA systems and processes for GCP/GLP, conduct internal and external audits, oversee deviations and CAPAs, support health authority inspections, develop SOPs and training, and provide quality input across cross-functional teams to ensure regulatory compliance and data integrity.

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.

Provide strategic and tactical regulatory review and approval of advertising, promotional and labeling materials for assigned products. Serve as primary regulatory reviewer and Promotional Review Committee chair, liaise with FDA OPDP (and PAAB in Canada as applicable), ensure promotional compliance with US/Canadian regulations, support submissions, train cross-functional teams, and maintain related records and processes.