Kyowa Kirin, Inc.- U.S.
Specialist III, Quality Assurance Operations
Kyowa Kirin, Inc.- U.S., Sanford, North Carolina, United States, 27330
Overview
Join Kyowa Kirin, Inc.- U.S. as a Specialist III, Quality Assurance Operations. This role is pivotal in launching and operating the Quality Assurance organization at the new monoclonal antibody drug substance manufacturing facility in Sanford, NC. Candidates will establish QA systems in a greenfield environment and later provide technical leadership through GMP readiness, technology transfer, and facility licensure for late clinical and commercial products. The role offers a unique opportunity to shape a culture of quality from the ground up while contributing to the delivery of life‑changing therapies. Responsibilities
Execute core QA activities such as batch record review, product disposition, and oversight of warehouse, laboratory, and supplier operations. Collaborate cross‑functionally to monitor site quality metrics, investigate deviations, and support continuous improvement initiatives. Leverage the Global Quality Management System in Veeva to ensure alignment with regulatory requirements, including data integrity standards. Participate in regulatory inspections and lead quality culture initiatives to maintain site excellence, integrity, and accountability. Act as an individual contributor with compassionate, people‑focused approach, proactively collaborating to create a supportive and inclusive environment. Qualifications
Advanced knowledge and expertise across GxP operations to support compliant manufacturing and achieve production goals. Independent execution of batch record review, Gemba walks, alarm responses, and logbook audits to uphold operational integrity and regulatory compliance. Support batch disposition and final product release by verifying documentation and quality standards for timely, compliant delivery. Support Warehouse and Incoming Quality activities to ensure materials meet defined specifications and quality requirements. Review and approve Change Controls, CAPAs, and Deviations in Veeva to ensure timely execution and regulatory alignment. Lead investigations of non‑conformances, deviations, laboratory exceptions, and cGMP issues; initiate CAPAs and communicate resolution plans. Conduct Supplier Quality activities including onboarding, monitoring, and recertification to maintain alignment with internal and external quality standards. Partner with Quality Control to ensure laboratory operations meet cGMP standards and support consistent, high‑quality testing practices. Monitor and analyze 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 support continuous improvement. Maintain site Quality Management System procedures within Veeva, aligning with the global QMS structure. Champion a culture of quality in all GxP areas within Site Operations by providing subject matter expertise focused on patient‑centric practices, sustainable compliance, and inspection readiness. Education
Bachelor’s degree in Life Sciences, Chemical Engineering, Pharmaceutical Sciences, Quality Assurance, or a related discipline required. Advanced degree (Master’s in Regulatory Affairs, Biotechnology, or Quality Systems) preferred. Experience
3–5 years of experience in Quality Assurance within biopharmaceutical manufacturing, executing technical and compliance activities across GMP QA functions including Document Control, Training, Inspections, Batch Disposition, Shop Floor QA, Laboratory QA, Vendor Qualification, and Incoming Quality Assurance. Assisted with QA batch disposition and final product release by verifying documentation accuracy and ensuring alignment with regulatory standards. Reviewed and approved batch records, conducted Gemba walks, responded to alarms, and audited logbooks to maintain operational integrity and compliance. Executed QA activities related to warehouse operations and incoming material inspections, verifying adherence to cGMP requirements and internal procedures. Reviewed and approved Change Controls, CAPAs, and Deviations, ensuring timely resolution and alignment with quality and regulatory expectations. Led investigations of non‑conformances, deviations, and laboratory exceptions; initiated and followed through on CAPAs to ensure effective resolution. Participated in regulatory inspections by demonstrating site compliance and executing QA activities aligned with inspection‑readiness standards. Experienced using Veeva in the areas of Document Management, Deviation, CAPA, Training, and Change Control. Executed daily QA operations at the manufacturing site while collaborating cross‑functionally to drive compliance and continuous improvement. Monitored and reported site quality metrics, including Deviations, CAPAs, OOS, OOT, and product disposition cycle times, to identify trends and improve performance. Contributed to greenfield site startup and biopharmaceutical manufacturing facility operations by establishing compliant QA systems and processes. Executed QA activities related to supplier qualification, including onboarding, monitoring, and recertification, to ensure alignment with quality standards. Collaborated with Quality Control to verify laboratory compliance and maintain data integrity in accordance with cGMP and regulatory requirements. Identified and escalated discrepancies or non‑compliant entries within the Quality Management System (Veeva); worked with process owners to resolve issues and ensure records met regulatory and internal standards. 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, 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. Salary & Benefits
Anticipated salary:
$106,300 to $138,800 . The total compensation package includes comprehensive benefits such as 401K with company matching Discretionary Profit Sharing Annual Bonus Program (Sales Bonus for Sales Jobs) Generous PTO and Holiday Schedule including 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 Location & Travel
Position is based on‑site in Sanford, NC. This is not a hybrid or remote role. Requires up to 10% domestic and limited international travel. Equal Employment Opportunity
Kyowa Kirin North America, Inc. is an equal employment opportunity employer. We provide employment opportunities 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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Join Kyowa Kirin, Inc.- U.S. as a Specialist III, Quality Assurance Operations. This role is pivotal in launching and operating the Quality Assurance organization at the new monoclonal antibody drug substance manufacturing facility in Sanford, NC. Candidates will establish QA systems in a greenfield environment and later provide technical leadership through GMP readiness, technology transfer, and facility licensure for late clinical and commercial products. The role offers a unique opportunity to shape a culture of quality from the ground up while contributing to the delivery of life‑changing therapies. Responsibilities
Execute core QA activities such as batch record review, product disposition, and oversight of warehouse, laboratory, and supplier operations. Collaborate cross‑functionally to monitor site quality metrics, investigate deviations, and support continuous improvement initiatives. Leverage the Global Quality Management System in Veeva to ensure alignment with regulatory requirements, including data integrity standards. Participate in regulatory inspections and lead quality culture initiatives to maintain site excellence, integrity, and accountability. Act as an individual contributor with compassionate, people‑focused approach, proactively collaborating to create a supportive and inclusive environment. Qualifications
Advanced knowledge and expertise across GxP operations to support compliant manufacturing and achieve production goals. Independent execution of batch record review, Gemba walks, alarm responses, and logbook audits to uphold operational integrity and regulatory compliance. Support batch disposition and final product release by verifying documentation and quality standards for timely, compliant delivery. Support Warehouse and Incoming Quality activities to ensure materials meet defined specifications and quality requirements. Review and approve Change Controls, CAPAs, and Deviations in Veeva to ensure timely execution and regulatory alignment. Lead investigations of non‑conformances, deviations, laboratory exceptions, and cGMP issues; initiate CAPAs and communicate resolution plans. Conduct Supplier Quality activities including onboarding, monitoring, and recertification to maintain alignment with internal and external quality standards. Partner with Quality Control to ensure laboratory operations meet cGMP standards and support consistent, high‑quality testing practices. Monitor and analyze 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 support continuous improvement. Maintain site Quality Management System procedures within Veeva, aligning with the global QMS structure. Champion a culture of quality in all GxP areas within Site Operations by providing subject matter expertise focused on patient‑centric practices, sustainable compliance, and inspection readiness. Education
Bachelor’s degree in Life Sciences, Chemical Engineering, Pharmaceutical Sciences, Quality Assurance, or a related discipline required. Advanced degree (Master’s in Regulatory Affairs, Biotechnology, or Quality Systems) preferred. Experience
3–5 years of experience in Quality Assurance within biopharmaceutical manufacturing, executing technical and compliance activities across GMP QA functions including Document Control, Training, Inspections, Batch Disposition, Shop Floor QA, Laboratory QA, Vendor Qualification, and Incoming Quality Assurance. Assisted with QA batch disposition and final product release by verifying documentation accuracy and ensuring alignment with regulatory standards. Reviewed and approved batch records, conducted Gemba walks, responded to alarms, and audited logbooks to maintain operational integrity and compliance. Executed QA activities related to warehouse operations and incoming material inspections, verifying adherence to cGMP requirements and internal procedures. Reviewed and approved Change Controls, CAPAs, and Deviations, ensuring timely resolution and alignment with quality and regulatory expectations. Led investigations of non‑conformances, deviations, and laboratory exceptions; initiated and followed through on CAPAs to ensure effective resolution. Participated in regulatory inspections by demonstrating site compliance and executing QA activities aligned with inspection‑readiness standards. Experienced using Veeva in the areas of Document Management, Deviation, CAPA, Training, and Change Control. Executed daily QA operations at the manufacturing site while collaborating cross‑functionally to drive compliance and continuous improvement. Monitored and reported site quality metrics, including Deviations, CAPAs, OOS, OOT, and product disposition cycle times, to identify trends and improve performance. Contributed to greenfield site startup and biopharmaceutical manufacturing facility operations by establishing compliant QA systems and processes. Executed QA activities related to supplier qualification, including onboarding, monitoring, and recertification, to ensure alignment with quality standards. Collaborated with Quality Control to verify laboratory compliance and maintain data integrity in accordance with cGMP and regulatory requirements. Identified and escalated discrepancies or non‑compliant entries within the Quality Management System (Veeva); worked with process owners to resolve issues and ensure records met regulatory and internal standards. 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, 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. Salary & Benefits
Anticipated salary:
$106,300 to $138,800 . The total compensation package includes comprehensive benefits such as 401K with company matching Discretionary Profit Sharing Annual Bonus Program (Sales Bonus for Sales Jobs) Generous PTO and Holiday Schedule including 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 Location & Travel
Position is based on‑site in Sanford, NC. This is not a hybrid or remote role. Requires up to 10% domestic and limited international travel. Equal Employment Opportunity
Kyowa Kirin North America, Inc. is an equal employment opportunity employer. We provide employment opportunities 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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