Specialist III, Quality Assurance Governance

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.

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 Kirins 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.

In this role you will ensure that all GxP areas within the Site Operations comply with current GxP standards and all applicable global regional and site procedures within Kyowa Kirins Quality Management System. You will design and execute governance frameworks that guide how quality is managed across the siteensuring consistency data integrity and inspection readiness. By managing core QA systems such as Change Control CAPAs Deviations Document Control and Training you will help build a sustainable quality culture rooted in operational excellence continuous improvement and patient focus.

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 into the Senior Manager Quality Assurance

Technical Skills Knowledge and Experience
Deliver technical expertise in Quality Assurance across all GxP operations to ensure manufacturing activities meet production targets while maintaining full regulatory compliance.
Quality System Management:
o Manage Quality Management System records in Veeva including Change Controls CAPAs Deviations and Training to ensure accurate documentation and timely execution.
o Maintain site procedures within the Global Quality Management System structure in Veeva ensuring alignment with internal standards and regulatory expectations.
o 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.
o 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.
Deviation and CAPA Management:
o 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.
Quality Metrics and Data Integrity:
o 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.
o Ensure compliance with current regulatory requirements for Data Integrity (ALCOA) as applicable to both paper and electronic records including 21 CFR Part 11.
o Communicate progress against goals across functions to the Site Leadership Team and to key stakeholders to ensure alignment and accountability.
Inspection Readiness and Continuous Improvement:
o Participate in regulatory inspections by demonstrating site compliance and executing Quality Assurance activities aligned with inspection-readiness expectations.

Individual contributor with the opportunity to potentially lead or coordinate task teams.

Education
Bachelors degree in Life Sciences Engineering or a related field required.
Advanced degree (e.g. Masters in Quality Regulatory Affairs or Biotechnology) preferred.

Experience
Demonstrate at least 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 Quality Assurance.
Experience leading QMS activities in Veeva (e.g. Change Control CAPA Deviation Document Management and Training) ensuring compliance with 21CFR Part 11 and Data Integrity (ALCOA) principles.
Actively participate in internal and external inspections demonstrating QA process ownership and an inspection readiness mindset.
Monitored and reported 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 Quality Assurance 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 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.

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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.

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