Director, IT Quality, Compliance and Technology Assurance

Kyowa Kirin North America•Princeton, NJ

3h•$185,000 - $220,000•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in Information Technology, Engineering, or Business field required.
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.
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.
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.

Nice To Haves

Advanced degree in Information Technology, Engineering field preferred

Responsibilities

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.
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.
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.
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.
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.

Benefits

401K with company match
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
Life & Disability Insurance
Concierge Services
Long Term Incentive Program (subject to job level and performance)
Pet Insurance
Tuition Assistance
Employee Referral Awards