Quality Engineer, FUME Lead; QS&C

Job Overview

Kyowa Kirin is a fast‑growing global specialty pharmaceutical company that applies state‑of‑the‑art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan‑based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization.

In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

The Quality Engineer, FUME Lead is a key individual contributor role with functional Quality authority leading and ensuring quality and compliance during the startup and operation of Kyowa Kirin’s Sanford, NC greenfield site. For this role, FUME refers to Facilities, Utilities, Maintenance, and Equipment, including associated instruments and asset lifecycle systems. This role is responsible for building, implementing, and sustaining Quality Engineering processes that enable GMP operations and long‑term regulatory compliance and inspection readiness.

As a member of the Quality Systems & Compliance team, the Quality Engineer, FUME Lead will set direction, build structure, and ensure compliant implementation with decision‑making authority for FUME‑related quality strategy, standards, and risk acceptance across equipment, utilities, facilities, and DS manufacturing processes. This role serves as the primary Quality Engineering SME for FUME systems and is accountable for regulatory compliance, inspection readiness, and audit defense, including direct interaction with health authorities and ownership of FUME‑related inspection responses and commitments.

This role independently prepares, presents, and defends Quality Engineering approaches and evidence during regulatory inspections, internal audits, and external audits.