Specialist III, Quality Assurance Operations

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.

The Quality Assurance Operations Specialist III plays a pivotal role in the launch and ongoing operations of the Quality Assurance organization at Kyowa Kirins 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 Kirins 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 organizations 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.

This role reports to the Senior Manager Quality Assurance

Technical Skills Knowledge and Experience
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 metricsincluding 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.
Individual contributor with responsibility to lead or work with cross-functional project teams.

Education
Bachelors degree in Life Sciences Chemical Engineering Pharmaceutical Sciences Quality Assurance or a related discipline required.
Advanced degree (e.g. Masters in Regulatory Affairs Biotechnology or Quality Systems) preferred.

Experience
Demonstrate 35 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.

Technical Skills
Proficient in MS Office Suite.
Proficient in using Quality Management Systems for documentation workflow management and compliance tracking; experience with Veeva is 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.

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.

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.

Requires up to 10% domestic and limited international travel.

The anticipated salary for this position will be $106300 to $138800. 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
• 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

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.

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) which is located at 510 Carnegie Center Dr. Princeton NJ 08540 USA and can be contacted by emailing Controllers data protection officer can be contacted at . Your personal data will be processed for the purposes of managing Controllers recruitment related activities which include setting up and conducting interviews and tests for applicants evaluating and assessing the results thereto and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (GDPR) as necessary for the purposes of the legitimate interests pursued by the Controller which are the solicitation evaluation and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software Inc. a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controllers behalf. Accordingly if you are located outside of the United States your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR if you are located in the European Union you have the right to request access to your personal data to request that your personal data be rectified or erased and to request that processing of your personal data be restricted. You also have the right to data portability and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data you may contact us by email at .

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.

#LI-SH1