Quality Engineer, Lead; QS&C

Kyowa Kirin is a Japanese-based company with a fast‑growing global specialty pharmaceutical business that applies state‑of‑the‑art biotechnology 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 Quality Engineer 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. The role supports quality oversight of Facilities, Utilities, Maintenance, and Equipment (FUME) and associated instruments and asset lifecycle systems, building and sustaining Quality Engineering processes that enable GMP operations, regulatory compliance, and audit readiness.

The position reports to the Sr. Manager, Quality Systems & Compliance.

• Act as the Quality Engineering lead for the Sanford site, setting priorities, workflows, and governance to ensure consistency and sustainability as the site grows.
• Lead and provide Quality oversight of GMP readiness activities for facility startup, including equipment, utilities, facilities, and process validation and documentation generation.
• Sustain compliance through lifecycle management of FUME systems, continuous improvement, and ongoing inspection readiness by reviewing evidence such as drawings, P&IDs, validation deliverables, and turnover packages.
• Drive structured problem solving for issues related to equipment, utilities, facilities, instruments, preventive maintenance (PM), and calibrations, contributing to the creation and review of PM and calibration programs.
• Execute and/or provide quality technical leadership of change controls and risk assessments (e.g., FMEA, hazard analysis), defining risk strategy, ensuring appropriate mitigation, and approving risk acceptance decisions for FUME systems.
• Partner with Engineering, Validation, and Maintenance teams to maintain inspection‑ready documentation and asset status, supporting startup activities and ensuring compliant execution.
• Review and approve work orders, CQV protocols and reports, change controls, deviations, and CAPAs associated with FUME systems, and serve as the Quality lead for FUME‑related internal, external, and regulatory audits.
• Present and defend Quality Engineering approaches and evidence during regulatory inspections, internal audits, and external audits.
• Lead cross‑functional project teams, providing Quality governance and influencing decision making across FUME‑related initiatives.

• Results‑oriented, able to navigate ambiguity and set clear outcomes that track progress and follow through on commitments.
• Adaptable to change, communicating with care, actively listening, and fostering inclusive collaboration.
• Strong organizational skills, attention to detail, and a solid work ethic, maintaining a growth mindset.
• Resourceful and proactive, challenging the status quo, driving innovation, and developing creative solutions.
• Enterprise‑wide perspective, working beyond siloed thinking to deliver cohesive, integrated solutions.

• Bachelor’s degree in engineering or a science‑related field required.
• Master’s degree in engineering or a science‑related field considered a plus.

• Minimum 8 + years of direct industry experience in a GxP‑regulated environment focused on Quality Engineering, including serving as a Quality SME during regulatory inspections and/or audits.
• Experience in qualification, validation, change control, and Quality Engineering activities.
• Direct experience with PM and Calibration systems, equipment lifecycle management, or CMMS platforms highly preferred.
• Familiarity with DS single‑use biologics operations or greenfield startup environments is preferred.

Salary range: $129,000 to $177,300 (actual offer may vary based on experience, skills, and qualifications).

• 401(k) with…