Manufacturing quality engineering

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; hematology oncology; 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.

Summary 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; hematology oncology; 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 workstreams, 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.

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.

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

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 other evidence supporting fitness for intended use.

Manage assigned lifecycle activities for facilities, utilities, manufacturing equipment, and associated instruments through change controls, deviations, CAPAs, periodic reviews, maintenance and calibration documentation, and continuous improvement activities.

Drive structured problem solving for issues related to equipment, utilities, facilities, instruments, preventive maintenance, and calibrations, ensuring actions are appropriately documented, risk‑based, and aligned with GMP expectations.

Execute risk assessments, including FMEA, hazard analysis, criticality assessments, and quality impact assessments; recommend mitigation actions and escalate risk acceptance decisions as appropriate.

Review and provide Quality input for work orders, commissioning and qualification documentation, validation protocols and reports, change controls, deviations, CAPAs, and procedures associated with assigned Quality Engineering activities.

Ensure assigned activities are consistent with data integrity expectations, 21 CFR Part 11 requirements, ALCOA+ principles, and applicable global, regional, and site procedures within Kyowa Kirin’s Quality Management System.

Partner with Engineering, Validation, Maintenance, Manufacturing, IT, and Quality stakeholders to maintain inspection‑ready documentation and enable compliant execution of startup, operational, and quality system activities.

Execute audit and inspection readiness actions for assigned Quality Engineering and quality system activities by preparing documentation, participating in walkthroughs, fulfilling requests, and completing assigned follow‑up actions.

Identify quality risks, documentation gaps, and process improvement opportunities within assigned scope and communicate them promptly to the Quality Engineer Lead and Quality Systems & Compliance management.

Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Bachelor’s degree in Life Sciences, Pharmaceutical Sciences or related field

Minimum 5 plus years of direct industry experience in a GxP‑regulated environment with a focus on Quality Engineering; including demonstrated experience serving as a Quality SME during regulatory inspections and/or audits.

Demonstrated 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 single‑use DS biologics operations or greenfield startup environments is preferred.

Physical Demands Must be able to work in an office and regulated manufacturing environment, including construction/start‑up phases, with appropriate PPE. This position is based on‑site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. Working Conditions Requires up to 10% domestic and limited international travel.

Annual Bonus Program (Sales Bonus for Sales Jobs)

Generous PTO and Holiday Schedule which includes Summer and Winter Shut‑Downs, Sick Days and, Volunteer Days

Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)

Long‑Term Incentive Program (subject to job level and performance)

Life & Disability Insurance

Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions.

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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