Senior Specialist, Quality Engineer

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.

Kyowa Kirin is a Japanese‑based company with 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. Our collective goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, from drug discovery to product development and commercialization.

The Sanford site is the first production facility in North America, and we are headquartered in Princeton, NJ, with offices in California and Mississauga, Ontario.

The Senior Specialist, Quality Engineer is a key individual contributor role within the Quality Systems & Compliance team supporting quality and compliance during the startup and operation of Kyowa Kirin’s Sanford, NC Greenfield site. This role provides hands‑on Quality Engineering support and technical quality oversight for facilities, utilities, equipment, maintenance, associated instruments, computerized systems, asset lifecycle systems, and Drug Substance manufacturing processes.

Working under the direction of the Quality Engineer Lead and Sr. Manager, Quality Systems & Compliance, this role helps implement and sustain Quality Engineering processes that enable GMP operations, regulatory compliance, audit defense, and compliant risk‑based decision making across manufacturing‑related systems.

The Senior Specialist is expected to own assigned Quality Engineering deliverables and work streams, provide technically sound recommendations, and escalate risks, gaps, or decisions requiring lead or management alignment. The role supports inspection readiness by preparing quality evidence, maintaining documentation discipline, and contributing to responses, commitments, and follow‑up actions from regulatory inspections, internal audits, and external audits.

As an individual contributor, you will take a compassionate and people‑focused approach to your work while collaborating with other functional groups, both internal and external, to create a supportive and inclusive environment that aligns with the organization’s values. Strong interpersonal skills, acknowledging diverse viewpoints, and building cross functional relationships will be the key driver to make decisions that meet both individual and team needs.

Key drivers for this role require accountability/ownership for delivering results and completing tasks, adapting to challenges while taking the initiative to problem solve with opportunities to grow, helping achieve business goals and keeping the patient first.

This position reports to the Sr. Manager, Quality Systems & Compliance and receives day‑to‑day Quality Engineering priorities, technical direction, and workstream alignment from the Quality Engineer Lead, as applicable.

Technical Skills, Knowledge, and Experience

• Implement and sustain assigned Quality Engineering processes for the Sanford site, executing priorities and deliverables in alignment with established standards, workflows, and governance.
• Provide Quality oversight and technical review of GMP readiness activities for facility startup, including equipment, utilities, facilities, process validation, and associated documentation generation.
• Own assigned Quality Engineering activities related to facilities, utilities, manufacturing equipment, and associated instruments, including review of applicable drawings, P&IDs, turnover packages, validation deliverables, maintenance documentation, and…