Specialist III, Quality Assurance Operations
Kyowa Kirin North America
About this role
The Quality Assurance Operations Specialist III will help establish and operate the QA function for a new monoclonal antibody drug substance manufacturing facility in Sanford, NC. This individual contributor role focuses on creating QA systems and processes, ensuring GxP compliance, and supporting GMP readiness, technology transfer, and facility licensure for clinical and commercial products. The position emphasizes building a culture of quality, inspection readiness, and cross-functional collaboration to support safe, compliant manufacturing.
Skills
Qualifications
About Kyowa Kirin North America
kyowakirin.comKyowa Kirin is a Japanese biopharmaceutical company that develops innovative specialty medicines, with a particular focus on antibody‑based therapies for cancer, kidney disease, and immune‑mediated disorders. The company pursues technology‑driven drug discovery across biologics and small molecules and maintains a broad global network of research, development, and commercial operations. Kyowa Kirin advances a pipeline through internal R&D and strategic partnerships (including biologics and CDMO collaborations) to bring life‑changing treatments to patients. It emphasizes patient‑centred value, scientific expertise, and sustainability in its mission to raise health and well‑being worldwide.
Recent company news
PR NewswireKyowa Kirin Integrates North America Businesses in Support of Company's 2030 Vision and Rapid Growth Trajectory
Mar 31, 2021
La Jolla InstituteLa Jolla Institute renews longtime collaboration with Kyowa Kirin, Inc.
Jan 18, 2022
New Jersey Business MagazineKyowa Kirin Completes New North American Headquarters in Princeton
Jul 11, 2023
BioSpaceHow Kyowa Kirin is Giving Employees a Voice in the Company’s Future
Dec 7, 2023
Contract PharmaKyowa Kirin to Invest $530M in New North American Biologics Manufacturing Facility
Jun 10, 2024
About Kyowa Kirin North America
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Leadership Team
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
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and employee contacts for Kyowa Kirin North America.
Salary
$106k – $139k
per year