Director, IT Quality, Compliance and Technology Assurance

Kyowa Kirin — Princeton, NJ, USA

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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: Kyowa Kirin Information & Communication Technology is seeking to add a dynamic and independent Director, IT Quality, Compliance and Technology Assurance.The role is accountable for establishing, governing, and continuously evolving the organization’s enterprise approach to technology assurance across both regulated (GxP) and non-regulated systems. This role provides authoritative, risk-based assurance leadership that enables safe, compliant, and efficient technology delivery at scale.The role owns the design and operation of the Computer Software Assurance (CSA) framework and associated Centre of Excellence (CoE), ensuring that technology risk is managed proportionately, decisions are defensible, and assurance outcomes support business agility rather than impede it. Essential Functions: Leadership•Own and define the global technology assurance strategy spanning GxP and non-GxP systems.•Act as the enterprise authority on risk-based assurance, providing clear, defensible guidance to IT, Quality, and business leadership.•Ensure assurance decisions are evidence-based, proportionate, and aligne..




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