Jobs at Kyowa Kirin

Leads the enterprise data governance program across commercial, medical, market access, and patient services functions. Owns data access governance, SOPs, governance committee operations, data lineage, data catalog and business glossary, source onboarding, data quality scorecards, vendor SLAs, and user enablement. Partners with technical, legal, privacy, compliance, and business teams to establish trusted, accessible, well-documented data and drive adoption through influence and cross-functional collaboration.

Lead adoption and enablement for Veeva CRM and Salesforce through training, documentation, communications, and user support. Partner with commercial stakeholders and IT to manage releases, UAT, metrics, and continuous improvement while ensuring compliance with policies and regulatory standards.

The Data Scientist develops advanced analytics, AI, machine learning, predictive models, and business intelligence solutions supporting pharmaceutical commercial strategies. Responsibilities include analyzing complex healthcare and longitudinal patient data, building scalable algorithms and automated analytics capabilities, integrating and governing cloud data, and communicating insights to technical and non-technical stakeholders. The role partners cross-functionally to support market intelligence, customer segmentation, targeting, promotional measurement, and data-driven decision-making across oncology, rare disease, and CNS franchises.

Leads startup and ongoing operations of GMP Quality Control laboratories for a monoclonal antibody manufacturing facility. Oversees analytical, biochemical, microbiological, raw material, bioassay, and stability testing; method transfer and validation; computerized laboratory systems; compliance with GxP, 21 CFR Part 11, and data integrity requirements. Builds and develops QC teams, manages deviations and CAPAs, establishes supplier qualification and laboratory KPIs, supports inspections, and coordinates cross-functional operational readiness activities.

Leads the enterprise technology assurance strategy across regulated GxP and non-regulated systems. Owns the Computer Software Assurance framework and Global CSA Centre of Excellence, establishes governance and risk-based assurance standards, supports audit readiness, and enables consistent regional capability. Advises senior IT, Quality, and business stakeholders while overseeing maturity planning, tooling strategy, regulatory alignment, inspection interactions, and escalation of methodology or risk matters.

Provide hands-on Quality Engineering support for Sanford NC greenfield site startup and operations. Own lifecycle and compliance activities for facilities, utilities, equipment, instruments, and computerized systems; perform risk assessments (FMEA), review qualification/validation deliverables, manage change controls/deviations/CAPAs, and support inspection readiness and audit responses to ensure GMP/GxP compliance.

Lead technical and compliance activities for QC Microbiology at a new monoclonal antibody manufacturing site. Establish QC microbiology lab systems, qualify methods/equipment/computerized systems, oversee environmental monitoring and contamination control, train and mentor staff, investigate microbial incidents and deviations, ensure data integrity and regulatory inspection readiness, and implement site quality metrics and operational procedures to enable GMP-compliant production.

Lead administration and compliance of the Veeva LMS for a GMP biopharma site, maintaining curricula, training records, audits, and regulatory compliance (21 CFR Part 11, EU Annex). Build and support eLearning (Articulate/Camtiva/Captivate), generate compliance reports, support inspections, and drive continuous improvement of training systems and processes. Provide cross-functional LMS support during tech transfer, licensure, and manufacturing startup activities.

Lead and set strategy for technology research supporting allogeneic cell and gene therapies. Oversee iPSC biology, immune cell differentiation, genome editing, and platform development; translate early research into CMC‑ready data packages; manage scientists and external partners; ensure regulatory and quality alignment; represent Technology Research in governance and scientific forums.

Lead planning, implementation, and management of IT infrastructure for a new biologics manufacturing site, covering networks, servers, security, cloud/on‑prem systems, PCS/MES/BMS support, compliance with GMP and cybersecurity standards, vendor management, and team leadership to align site IT with global standards.

This position is for candidates to express their interest in future job openings by joining the Kyowa Kirin Talent Community.