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Kyowa Kirin, Inc.- U.S. · 2 days ago

Specialist III, Quality Assurance Governance

Sanford, NC

Full-time

Onsite

Mid, Senior Level

$106K/yr - $139K/yr

3+ years exp

Kyowa Kirin is a fast-growing global specialty pharmaceutical company focused on delivering novel medicines. The Specialist III – Quality Assurance Governance will establish foundational QA systems and processes at a new drug manufacturing facility, ensuring compliance with GxP standards and leading quality assurance initiatives.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

Deliver technical expertise in Quality Assurance across all GxP operations to ensure manufacturing activities meet production targets while maintaining full regulatory compliance

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 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

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 Quality Assurance activities aligned with inspection-readiness expectations

Qualification

Quality AssuranceGxP ComplianceVeevaCAPA ManagementData IntegrityQuality MetricsTechnical LeadershipMS Office SuiteContinuous ImprovementInterpersonal SkillsOrganizational SkillsCollaboration

Required

Bachelor's degree in Life Sciences, Engineering, or a related field required

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

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

Preferred

Advanced degree (e.g., Master's in Quality, Regulatory Affairs, or Biotechnology) preferred

Experience with Veeva is preferred

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

Company

Kyowa Kirin, Inc.- U.S.

Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines.

Founded in 1949

Princeton, New Jersey, US

501-1000 employees

https://kkna.kyowakirin.com/

H1B Sponsorship

Kyowa Kirin, Inc.- U.S. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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Trends of Total Sponsorships

2025 (1)

2022 (1)

2021 (1)