Specialist III, Quality Assurance Operations

Kyowa Kirin North America•Sanford, NJ

3d•Onsite

About The Position

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 Assurance Operations Specialist III plays a pivotal role in the launch and ongoing operations of the Quality Assurance organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC. Starting in a greenfield environment, you will help establish QA systems and processes, then transition into providing technical leadership through GMP readiness, technology transfer, and facility licensure for late clinical and commercial products. You will ensure that all GxP areas within the Site Operations maintain full compliance with current GxP standards and all applicable global, regional, and site procedures within Kyowa Kirin’s Quality Management System. This role offers a unique opportunity to shape a culture of quality from the ground up while contributing to the delivery of life-changing therapies. Key responsibilities include executing core QA activities such as batch record review, product disposition, and oversight of warehouse, laboratory, and supplier operations. You will collaborate cross-functionally to monitor site quality metrics, investigate deviations, and support continuous improvement initiatives. Leveraging the Global Quality Management System in Veeva, you will ensure alignment with regulatory requirements, including data integrity standards. Through active participation in regulatory inspections and leadership in quality culture initiatives, you will help ensure the site operates with excellence, integrity, and accountability. 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.

Requirements

Bachelor’s degree in Life Sciences, Chemical Engineering, Pharmaceutical Sciences, Quality Assurance, or a related discipline required.
Demonstrate 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 ensure 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 and performed 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.
Proficient in MS Office Suite.
Proficient in using Quality Management Systems for documentation, workflow management, and compliance tracking; experience with Veeva is preferred.
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.
Must be able to work in a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE.
This position is based on-site in Sanford, NC.
Requires up to 10% domestic and limited international travel.

Nice To Haves

Advanced degree (e.g., Master’s in Regulatory Affairs, Biotechnology, or Quality Systems) preferred.
Experienced using Veeva in the areas of Document Management, Deviation, CAPA, Training, and Change Control.

Responsibilities

Apply advanced Quality Assurance expertise across GxP operations to support compliant manufacturing and ensure production goals are met.
Independently execute batch record review and approval, participate in Gemba walks, coordinate alarm responses, and conduct logbook audits to uphold operational integrity and regulatory compliance.
Participate in batch disposition and support final product release by verifying documentation and quality standards to enable timely and compliant delivery.
Support Warehouse and Incoming Quality activities by ensuring materials meet defined specifications and quality requirements.
Review and approve Change Controls, CAPAs, and Deviations in Veeva to ensure timely execution and alignment with regulatory and quality standards.
Identify and escalate discrepancies or non-compliant entries within the Quality Management System (Veeva), 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 CAPAs and communicate resolution plans to drive effective compliance.
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, support continuous improvement, and ensure compliance.
Maintain site Quality Management System procedures within Veeva, leveraging the global QMS structure to ensure consistency and regulatory alignment.
Champion a culture of quality in all GxP areas within the Site Operations by providing subject matter expertise focused on patient-centric practices, sustainable compliance, and inspection readiness.
Participate in regulatory inspections by demonstrating site compliance and contributing to Quality Assurance activities.
Develop, monitor, and communicate progress against goals across functions, to the Site Leadership Team, and to key stakeholders to ensure alignment and accountability.
Ensure compliance with current regulatory requirements for Data Integrity (ALCOA+) as applicable to paper and electronic records, including 21 CFR Part 11.

Benefits

401K with company matching
Discretionary Profit Sharing
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