Quality Engineer, Lead (QS&C)

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.

Summary of Job :

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. For this role, the Quality Engineer Lead will support quality oversite to the following areas: Facilities, Utilities, Maintenance, and Equipment otherwise referred to as FUME, 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, inspection readiness, and audit defense including interactions with health authorities while ensuring compliant implementation and risk acceptance across FUME and Drug Substance manufacturing processes.

This role independently prepares, presents, and defends Quality Engineering approaches and evidence during 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 align 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.

Reporting Relationship:

This position reports to the Sr. Manager, Quality Systems Compliance.

Essential Functions :

Technical Skills, Knowledge, and Experience

• Act as the Quality Engineering lead for the Sanford site, owning priorities and outcomes and establish clear standards, 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; confirm readiness of systems by reviewing evidence such as drawings, P IDs, validation deliverables, and turnover packages to ensure fitness for intended use.
• Drive structured problem solving for issues related to equipment, utilities, facilities, instruments, PMs, and calibrations and contribute to the creation of the Preventative Maintenance (PM) and calibration programs, including review of plans, intervals, and criticality assessments.
• Execute and/or provide quality technical leadership of change controls and risk assessments (e.g., FMEA, hazard analysis), including defining risk strategy, ensuring appropriate mitigation, and approving risk acceptance decisions of FUME systems.
• Drive structure problem-solving for issues related to equipment, utilities, facilities, calibrations, and PMs and ensure all activities are consistent with data integrity expectations, Part 11 requirements, and ALCOA++ principles.
• Partner with Engineering, Validation, and Maintenance Teams to maintain inspection-ready documentation and asset status and work collaboratively across teams to support startup activities and ensure 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, including inspection preparation, execution, and follow-up.

Non-Technical Skills

Results-oriented and able to navigate ambiguity. Demonstrates the ability to set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Responds promptly, takes accountability, and manages tasks efficiently. Adapts to change with clarity, patience, and understanding while influencing peers and key stakeholders through evolving challenges. In this role, …