Kyowa Kirin, Inc.- U.S.
Specialist III, Quality Assurance Governance
Kyowa Kirin, Inc.- U.S., Sanford, North Carolina, United States, 27330
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. The company translates science into smiles by delivering therapies where no adequate treatments exist, working from drug discovery to product development and commercialization. In North America, Kyowa Kirin is headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.
As the Specialist III – Quality Assurance Governance, you will play a critical role in the start‑up and ongoing operations of the Quality Assurance organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC. You will begin in a greenfield environment, establishing foundational QA systems and processes. As the site progresses through GMP readiness, technology transfer, and facility licensure for late clinical and commercial manufacturing, you will provide technical leadership to ensure quality and compliance are embedded in every step.
Responsibilities
Deliver technical expertise in Quality Assurance across all GxP operations to ensure manufacturing activities meet production targets while maintaining full regulatory compliance.
Manage Quality Management System records in Veeva, including Change Controls, CAPAs, Deviations, and Training, to ensure accurate documentation and timely execution.
Maintain site procedures within the Global Quality Management System structure in Veeva, ensuring alignment with internal standards and regulatory expectations.
Provide subject‑matter expertise to foster a robust culture of quality focused on patient‑centric practices, sustainable compliance, and inspection readiness across all GxP areas.
Identify and escalate discrepancies or non‑compliant entries within the Quality Management System (Veeva); collaborate with process owners to resolve issues and ensure records meet regulatory and internal standards.
Lead investigations of non‑conformances, deviations, laboratory exceptions, and other cGMP issues; initiate and communicate CAPAs to drive effective and compliant identification, prevention, and/or correction of quality issues.
Define and monitor key performance indicators for site quality metrics, including Deviations, CAPAs, Change Controls, OOS, Invalid Assays, OOT, Equipment Failures, EM data trends, Stability Trends, and Product Disposition Cycle‑times, to identify trends and drive continuous improvement.
Ensure compliance with current regulatory requirements for data integrity (ALCOA+) as applicable to both paper and electronic records, including 21 CFR Part 11.
Communicate progress against goals across functions to the Site Leadership Team and key stakeholders to ensure alignment and accountability.
Participate in regulatory inspections by demonstrating site compliance and executing Quality Assurance activities aligned with inspection‑readiness expectations.
Education
Bachelor’s degree in Life Sciences, Engineering, or a related field required.
Advanced degree (e.g., Master’s in Quality, Regulatory Affairs, or Biotechnology) preferred.
Experience
3–5 years of experience in Quality Assurance within biopharmaceutical manufacturing, providing technical and compliance leadership across GMP QA functions such as Document Control, Training, Inspections, Batch Disposition, Shop Floor QA, Laboratory QA, Vendor Qualification, and Incoming QA.
Experience leading QMS activities in Veeva (e.g., Change Control, CAPA, Deviation, Document Management, and Training) ensuring compliance with 21 CFR Part 11 and Data Integrity (ALCOA+) principles.
Active participation in internal and external inspections, demonstrating QA process ownership and an inspection readiness mindset.
Monitoring and reporting quality metrics to identify trends, drive continuous improvement, and maintain alignment with site and regulatory expectations.
Conducting investigations of non‑conformances, deviations, and laboratory exceptions; initiating and following through on CAPAs to ensure effective resolution.
Applying QA expertise within a manufacturing site environment, collaborating cross‑functionally to ensure consistent execution of quality processes.
Contributing to the start‑up and operation of biopharmaceutical manufacturing facilities by establishing QA systems and practices that support sustainable compliance and operational readiness.
Technical Skills
Proficient in MS Office Suite.
Proficient in using Quality Management Systems for documentation, workflow management, and compliance tracking; experience with Veeva preferred.
Non‑Technical Skills
Results‑oriented and able to navigate ambiguity.
Set clear outcomes, track progress, follow through on commitments, and ensure 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, challenging the status quo, driving innovation, and developing creative solutions.
Apply an enterprise‑wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
Compensation & Benefits Salary range: $106,300 to $138,800. The actual salary offered at commencement may vary based on experience, skill set, education, and other factors.
401(k) with company matching
Discretionary Profit Sharing
Annual Bonus Program
Generous PTO and Holiday Schedule (including Summer and Winter shutdowns, sick days, and volunteer days)
Healthcare benefits (medical, dental, prescription drugs, 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
Location & Travel Position base: Sanford, NC (on‑site). This is a non‑hybrid, non‑remote role. Requires up to 10 % domestic travel and limited international travel.
Equal Opportunity Employment 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 citizenship status or any other category protected by law.
Recruitment & Staffing Agencies 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.
Contact & Privacy Your personal data will be collected and processed by Kyowa Kirin, Inc. (“Controller”) for recruitment. For privacy inquiries, contact us at
usprivacyoffice@kyowakirin.com .
#J-18808-Ljbffr
As the Specialist III – Quality Assurance Governance, you will play a critical role in the start‑up and ongoing operations of the Quality Assurance organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC. You will begin in a greenfield environment, establishing foundational QA systems and processes. As the site progresses through GMP readiness, technology transfer, and facility licensure for late clinical and commercial manufacturing, you will provide technical leadership to ensure quality and compliance are embedded in every step.
Responsibilities
Deliver technical expertise in Quality Assurance across all GxP operations to ensure manufacturing activities meet production targets while maintaining full regulatory compliance.
Manage Quality Management System records in Veeva, including Change Controls, CAPAs, Deviations, and Training, to ensure accurate documentation and timely execution.
Maintain site procedures within the Global Quality Management System structure in Veeva, ensuring alignment with internal standards and regulatory expectations.
Provide subject‑matter expertise to foster a robust culture of quality focused on patient‑centric practices, sustainable compliance, and inspection readiness across all GxP areas.
Identify and escalate discrepancies or non‑compliant entries within the Quality Management System (Veeva); collaborate with process owners to resolve issues and ensure records meet regulatory and internal standards.
Lead investigations of non‑conformances, deviations, laboratory exceptions, and other cGMP issues; initiate and communicate CAPAs to drive effective and compliant identification, prevention, and/or correction of quality issues.
Define and monitor key performance indicators for site quality metrics, including Deviations, CAPAs, Change Controls, OOS, Invalid Assays, OOT, Equipment Failures, EM data trends, Stability Trends, and Product Disposition Cycle‑times, to identify trends and drive continuous improvement.
Ensure compliance with current regulatory requirements for data integrity (ALCOA+) as applicable to both paper and electronic records, including 21 CFR Part 11.
Communicate progress against goals across functions to the Site Leadership Team and key stakeholders to ensure alignment and accountability.
Participate in regulatory inspections by demonstrating site compliance and executing Quality Assurance activities aligned with inspection‑readiness expectations.
Education
Bachelor’s degree in Life Sciences, Engineering, or a related field required.
Advanced degree (e.g., Master’s in Quality, Regulatory Affairs, or Biotechnology) preferred.
Experience
3–5 years of experience in Quality Assurance within biopharmaceutical manufacturing, providing technical and compliance leadership across GMP QA functions such as Document Control, Training, Inspections, Batch Disposition, Shop Floor QA, Laboratory QA, Vendor Qualification, and Incoming QA.
Experience leading QMS activities in Veeva (e.g., Change Control, CAPA, Deviation, Document Management, and Training) ensuring compliance with 21 CFR Part 11 and Data Integrity (ALCOA+) principles.
Active participation in internal and external inspections, demonstrating QA process ownership and an inspection readiness mindset.
Monitoring and reporting quality metrics to identify trends, drive continuous improvement, and maintain alignment with site and regulatory expectations.
Conducting investigations of non‑conformances, deviations, and laboratory exceptions; initiating and following through on CAPAs to ensure effective resolution.
Applying QA expertise within a manufacturing site environment, collaborating cross‑functionally to ensure consistent execution of quality processes.
Contributing to the start‑up and operation of biopharmaceutical manufacturing facilities by establishing QA systems and practices that support sustainable compliance and operational readiness.
Technical Skills
Proficient in MS Office Suite.
Proficient in using Quality Management Systems for documentation, workflow management, and compliance tracking; experience with Veeva preferred.
Non‑Technical Skills
Results‑oriented and able to navigate ambiguity.
Set clear outcomes, track progress, follow through on commitments, and ensure 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, challenging the status quo, driving innovation, and developing creative solutions.
Apply an enterprise‑wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.
Compensation & Benefits Salary range: $106,300 to $138,800. The actual salary offered at commencement may vary based on experience, skill set, education, and other factors.
401(k) with company matching
Discretionary Profit Sharing
Annual Bonus Program
Generous PTO and Holiday Schedule (including Summer and Winter shutdowns, sick days, and volunteer days)
Healthcare benefits (medical, dental, prescription drugs, 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
Location & Travel Position base: Sanford, NC (on‑site). This is a non‑hybrid, non‑remote role. Requires up to 10 % domestic travel and limited international travel.
Equal Opportunity Employment 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 citizenship status or any other category protected by law.
Recruitment & Staffing Agencies 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.
Contact & Privacy Your personal data will be collected and processed by Kyowa Kirin, Inc. (“Controller”) for recruitment. For privacy inquiries, contact us at
usprivacyoffice@kyowakirin.com .
#J-18808-Ljbffr