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Princeton, New Jersey, United States
Hybrid
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 aligned with regulatory expectations and organizational risk appetite.
• Design, stand up, and lead the Global CSA Centre of Excellence.
• Define the CoE mandate, operating model, RACI, and engagement model across global and regional teams.
• Lead through authority and structure, enabling regional capability owners rather than centralized execution.
• Ensure the CoE operates within its defined authority, maintaining structural separation from delivery execution while providing oversight and interpretation support.
Technology Assurance Framework and Governance
• Establish and maintain the CSA framework, lifecycle, governance model, and standards as the Accountable authority for methodology and interpretation within Operational Governance, aligned to the non delegable enterprise boundaries defined in the CSA Governance Framework
• Define assurance decision points, artefact expectations, and inspection narratives that are consistent, scalable, and audit ready.
• Ensure alignment with global Quality, Audit, and Regulatory stakeholders while maintaining independence of technical judgement.
• Ensure unresolved matters relating to methodology, interpretation, or cross regional consistency are escalated to the CSA Steering Committee in accordance with the Decision Authority & Risk Acceptance Model.
Organizational Enablement and Capability
• Enable sustainable CSA capability across regions through governance, coaching, and targeted enablement.
• Oversee the development of Regional CSA Champions and ensure consistent application of CSA principles.
• Reduce reliance on central assurance through clear frameworks and decision structures.
Tooling and Maturity Evolution
• Define the long-term CSA maturity roadmap, including the role of tooling and automation.
• Ensure tooling decisions are evidence-led, supporting a proven CSA operating model rather than driving it.
• Sponsor targeted experimentation to inform future enterprise tooling standards.
Senior Stakeholder Engagement
• Act as a trusted advisor to the CIO, IT leadership team, Quality leadership, and the CSA Steering Committee, ensuring governance decisions incorporate independent QA oversight perspective and are consistent with enterprise risk posture.
• Represent technology assurance in enterprise governance forums.
• Provide clear, calm leadership in inspection, audit, and regulatory interactions.
Requirements:
Education
• Bachelor’s degree in Information Technology, Engineering, or Business field required.
• Advanced degree in Information Technology, Engineering field preferred
Experience
• A strong computer science background, demonstrated through industry experience
• At least 15 years’ experience in technology assurance, IT quality, validation, or related disciplines within regulated industries (e.g. pharmaceutical, life sciences).
• Deep, demonstrable expertise in computer system validation (CSV), Computer Software Assurance (CSA), and risk-based assurance in regulated environments.
• Strong understanding of global regulatory expectations (e.g. FDA CSA guidance, GAMP, EU Annex 11) and how to apply them pragmatically.
Technical Skills
• Proven ability to design assurance frameworks and governance models, not just execute validation activities.
• Strong grasp of modern IT delivery models, including COTS, SaaS, cloud platforms, and configurable systems.
Leadership Skills
• Recognized as a subject-matter authority with strong personal credibility.
• Comfortable operating with ambiguity and defining structure where none exists.
• Leads through clarity, proportionate control, and trust rather than bureaucracy.
• Able to balance regulatory rigor with business pragmatism.
• Demonstrates disciplined governance behavior, ensuring decisions and escalations follow the authority boundaries and thresholds defined in the CSA Governance Framework.
Working Conditions:
Requires up to 10% domestic and international travel
The anticipated salary for this position will be $185,000 to $220,000. 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:
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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