Kyowa Kirin, Inc.- U.S.
Specialist III, Quality Assurance Governance
Kyowa Kirin, Inc.- U.S., Sanford, North Carolina, United States, 27330
Specialist III, Quality Assurance Governance
Sanford, NC
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.
As the Specialist III – Quality Assurance Governance, you will play a critical role in the start‑up and ongoing operations of the QA organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC.
You will begin in a greenfield environment, where you will help establish 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
Ensure that all GxP areas within Site Operations comply with current GxP standards and all applicable global, regional, and site procedures within Kyowa Kirin’s Quality Management System.
Design and execute governance frameworks that guide how quality is managed across the site — ensuring consistency, data integrity, and inspection readiness.
Manage core QA systems such as Change Control, CAPAs, Deviations, Document Control, and Training, helping build a sustainable quality culture rooted in operational excellence, continuous improvement, and patient focus.
Proactively collaborate with teams to create a supportive and inclusive environment, using strong interpersonal skills to manage relationships thoughtfully and make decisions that meet both individual and team needs.
Deliver technical expertise in QA across all GxP operations to ensure manufacturing activities meet production targets while maintaining full regulatory compliance.
Technical Skills, Knowledge, and Experience
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 expedite discrepancies or non‑compliant entries within the Quality Management System, collaborating 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 to key stakeholders to ensure alignment and accountability.
Participate in regulatory inspections by demonstrating site compliance and executing QA 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
At least 3‑5 years of experience in QA 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, training) ensuring compliance with 21CFR Part 11 and Data Integrity 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.
Conducted investigations of non‑conformances, deviations, and laboratory exceptions; initiated and followed through on CAPAs to ensure effective resolution.
Applied QA expertise within a manufacturing site environment, collaborating cross‑functionally to ensure consistent execution of quality processes.
Contributed 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; 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.
Responsive, accountable, and efficient in task management.
Adaptive, proactive, and collaborative with respect, integrity, and humility.
Resourceful, innovative, and focused on continuous learning and growth.
Inclusive, culturally sensitive, and communicative with active listening.
Location & Travel Must be able to work in a regulated manufacturing environment, including construction/start‑up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law. Requires up to 10% domestic and limited international travel.
Salary & Benefits The anticipated salary for this position will be $106,300 to $138,800. The actual salary offered may vary based on experience, skill set, education, and business needs.
Benefits include:
401(k) with company matching
Discretionary profit sharing
Annual bonus program
Generous PTO and holiday schedule
Healthcare benefits (medical, dental, vision)
Well‑being and work/life programs
Long‑term incentive program (subject to level and performance)
Life & disability insurance
Pet insurance
Tuition assistance
Employee referral awards
Equal Employment Opportunity Kyowa Kirin North America, Inc. is an equal opportunity employer. We 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. We are committed to diversity, inclusion, and compliance with all applicable laws.
Privacy & Data Protection When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”). The Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for recruitment purposes in accordance with applicable privacy laws.
Applicants located outside the United States may be required to provide additional information for lawful processing.
#J-18808-Ljbffr
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.
As the Specialist III – Quality Assurance Governance, you will play a critical role in the start‑up and ongoing operations of the QA organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC.
You will begin in a greenfield environment, where you will help establish 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
Ensure that all GxP areas within Site Operations comply with current GxP standards and all applicable global, regional, and site procedures within Kyowa Kirin’s Quality Management System.
Design and execute governance frameworks that guide how quality is managed across the site — ensuring consistency, data integrity, and inspection readiness.
Manage core QA systems such as Change Control, CAPAs, Deviations, Document Control, and Training, helping build a sustainable quality culture rooted in operational excellence, continuous improvement, and patient focus.
Proactively collaborate with teams to create a supportive and inclusive environment, using strong interpersonal skills to manage relationships thoughtfully and make decisions that meet both individual and team needs.
Deliver technical expertise in QA across all GxP operations to ensure manufacturing activities meet production targets while maintaining full regulatory compliance.
Technical Skills, Knowledge, and Experience
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 expedite discrepancies or non‑compliant entries within the Quality Management System, collaborating 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 to key stakeholders to ensure alignment and accountability.
Participate in regulatory inspections by demonstrating site compliance and executing QA 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
At least 3‑5 years of experience in QA 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, training) ensuring compliance with 21CFR Part 11 and Data Integrity 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.
Conducted investigations of non‑conformances, deviations, and laboratory exceptions; initiated and followed through on CAPAs to ensure effective resolution.
Applied QA expertise within a manufacturing site environment, collaborating cross‑functionally to ensure consistent execution of quality processes.
Contributed 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; 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.
Responsive, accountable, and efficient in task management.
Adaptive, proactive, and collaborative with respect, integrity, and humility.
Resourceful, innovative, and focused on continuous learning and growth.
Inclusive, culturally sensitive, and communicative with active listening.
Location & Travel Must be able to work in a regulated manufacturing environment, including construction/start‑up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law. Requires up to 10% domestic and limited international travel.
Salary & Benefits The anticipated salary for this position will be $106,300 to $138,800. The actual salary offered may vary based on experience, skill set, education, and business needs.
Benefits include:
401(k) with company matching
Discretionary profit sharing
Annual bonus program
Generous PTO and holiday schedule
Healthcare benefits (medical, dental, vision)
Well‑being and work/life programs
Long‑term incentive program (subject to level and performance)
Life & disability insurance
Pet insurance
Tuition assistance
Employee referral awards
Equal Employment Opportunity Kyowa Kirin North America, Inc. is an equal opportunity employer. We 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. We are committed to diversity, inclusion, and compliance with all applicable laws.
Privacy & Data Protection When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”). The Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for recruitment purposes in accordance with applicable privacy laws.
Applicants located outside the United States may be required to provide additional information for lawful processing.
#J-18808-Ljbffr