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 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; 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 Kirins 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.

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 organizations 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.

Essential Functions:

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 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 Kirins 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.

Non-Technical Skills:
Results-oriented and able to navigate ambiguity you set clear outcomes track progress follow through on commitments and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly take accountability and manage tasks efficiently. Adapt to change with clarity patience and understanding guiding teams through evolving challenges. 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.

Requirements:

Education
Bachelors degree in Life Sciences Pharmaceutical Sciences or related field

Experience
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. 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.

Working Conditions:

Requires up to 10% domestic and limited international travel

The anticipated salary for this position will be $116000 to $152300. 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.

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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Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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