Senior Specialist, Digital Quality (Quality Systems & Compliance)

The posting, as Kyowa Kirin North America wrote it

Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation, dedicated to discovering and advancing treatments for diseases in which unmet need is greatest. Based in Japan with worldwide operations, we work across the continuum from drug discovery to commercialization, guided by our commitment to patients and their families.

Our research teams, located in California and around the world, are focused on developing the next generation of antibody, cell, and gene therapies, with particular emphasis on bone and mineral disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients, and healthcare providers, and since 2018 we have introduced four new therapies serving patients with progressive illnesses often in need of new therapeutic alternatives.

Our culture is grounded in our values: Commitment to Life , Integrity , Innovation , and Teamwork/Wa , and brought to life through the Kabegoe Principles, which define the behaviors and actions that guide how we work together to deliver meaningful impact for patients.

We’re proud of the progress we’ve made and mindful of the countless individuals still waiting for their own breakthroughs. A commitment to making people smile unites our efforts. Learn more at www.kkna.kyowakirin.com .

Summary

The Senior Specialist, Digital Quality (Quality Systems & Compliance) serves as the Quality business lead and system owner for laboratory digital systems, including LabVantage LIMS, analytical instrument platforms, and related interfaces supporting GxP operations at Kyowa Kirin’s Sanford, NC manufacturing site. This role ensures laboratory computerized systems remain compliant, validated, inspection-ready, and aligned with regulatory requirements, including 21 CFR Part 11, EU Annex 11, ALCOA++, and data integrity standards.

Partnering with IT, QC Operations, Automation, Engineering, system vendors, and global stakeholders, the incumbent oversees system lifecycle management, validation, change control, user access, periodic reviews, enhancements, and continuous improvement. As the business administrator for LabVantage and related systems, this role translates business requirements into compliant digital solutions, supports system integrations and investigations, and ensures the reliable use of laboratory data and technology.

This position reports to the Sr. Manager, Quality Systems & Compliance and receives day-to-day Digital Quality priorities, technical direction, and workstream alignment from the Digital Quality Lead, as applicable.

Essential Functions

Technical Skills, Knowledge, and Experience

• Serve as Quality System Owner and Business Administrator for LabVantage LIMS and associated laboratory computerized systems, ensuring systems remain compliant, validated, fit for intended use, and aligned with business requirements.
• Partner with Information Technology, laborat

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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 Controller’s 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 usprivacyoffice@kyowakirin.com .

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.

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