Global Director, IT Quality & Technology Assurance

Kyowa Kirin North America

Princeton (NJ)

Hybrid

USD 185,000 - 220,000

Full time

14 days+
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Benefits offered by this job

401K with company match
Annual Bonus Program
Generous PTO
Healthcare Benefits

Job summary

Kyowa Kirin North America seeks a dynamic Director, IT Quality, Compliance and Technology Assurance to establish and govern the enterprise approach to technology assurance across both regulated and non-regulated systems. You will lead the CSA framework and CoE, ensuring risk-based, evidence-driven decisions that support business agility and compliance.

The role partners with IT, Quality, and senior leadership to align governance with global regulatory expectations, drive continuous improvement,

Qualifications

  • Bachelor’s degree in IT, engineering, or business required; advanced degree preferred.
  • 15+ years in technology assurance, IT quality, validation, or related regulated disciplines.
  • Expertise in CSV, CSA, and risk-based assurance in regulated environments.

Responsibilities

  • Define and lead global technology assurance strategy across GxP and non-GxP.
  • Act as enterprise authority on risk-based assurance for IT, Quality, and leadership.
  • Establish and operate the CSA Centre of Excellence and governance models.
  • Engage senior stakeholders and ensure regulatory alignment.

Skills

Technology assurance
CSV/CSA
Regulatory knowledge
Leadership
Stakeholder engagement

Education

Bachelor's degree in IT/Engineering/Business
Advanced degree

Tools

GxP knowledge

Job description

Kyowa Kirin North America seeks a dynamic Director, IT Quality, Compliance and Technology Assurance to establish and govern the enterprise approach to technology assurance across both regulated and non-regulated systems. You will lead the CSA framework and CoE, ensuring risk-based, evidence-driven decisions that support business agility and compliance.

The role partners with IT, Quality, and senior leadership to align governance with global regulatory expectations, drive continuous improvement,

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