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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.

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.

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.

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.

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.

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