Quality Engineer, FUME Lead (QS&C) at Kyowakirinusa90

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. As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts. This position reports to the Sr. Manager, Quality Systems & Compliance. 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, you will exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions. Individual contributor, with responsibility to lead cross-functional project teams and provide Quality governance and influence decision making across FUME related initiatives. Education • Bachelor’s degree in engineering or science related field required. • Master’s degree in engineering or science related field considered a plus. Experience • Minimum 8 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 DS single-use biologics operations or greenfield startup environments is preferred. Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law. This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role. This role may require travel up to 5% domestic and typically limited international travel. The anticipated salary for this position will be $129,000 to $193,500. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: • 401K with company matching • 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) • HSA & FSA Programs • Well-Being and Work/Life Programs • Long-Term Incentive Program (subject to job level and performance) • Life & Disability Insurance • Concierge Service • Pet Insurance • Tuition Assistance • Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 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