Manager, R&D Quality Assurance- GCP

Kyowa Kirin North America(5 days ago)

HybridFull TimeSenior$155,000 - $170,000Quality Assurance

About this role

The R&D QA Manager at Kyowa Kirin oversees quality assurance systems, conducts audits, and supports regulatory submissions in the drug development process. The role involves collaboration with scientific and regulatory teams to ensure compliance and quality in clinical trials and research activities.

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Required Skills

GCP
GLP
Audit
CAPA
Regulatory
Risk Assessment
Quality Systems
Veeva
GXP
Documentation

Qualifications

Bachelor’s degree in Life Science or related field

About Kyowa Kirin North America

kyowakirin.com

Kyowa 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.

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