Global Director, IT Quality, Compliance & CSA

Kyowa Kirin, Inc.- U.S.; Princeton (NJ); On-site; USD 185,000 - 220,000; Full time

Benefits offered by this job

401K with company match

Annual Bonus Program

Generous PTO and Holiday Schedule

Healthcare Benefits

Job summary

Kyowa Kirin North America is seeking a dynamic Director, IT Quality, Compliance and Technology Assurance to establish and govern the enterprise approach to technology assurance across GxP and non-regulated systems. You will own the CSA framework design, lead the CoE, and ensure risk-based, evidence-driven guidance for IT, Quality, and business leadership.

Responsibilities include defining assurance points, establishing governance, and partnering with regulatory stakeholders to maintain

Qualifications

• Bachelor's degree in Information Technology, Engineering, or Business field required.
• Advanced degree in Information Technology, Engineering field preferred.
• At least 15 years’ experience in technology assurance, IT quality, validation, or related disciplines within regulated industries.

Responsibilities

• Own and define the global technology assurance strategy spanning GxP and non-GxP systems.
• Lead the Global CSA Centre of Excellence and define its mandate and operating model.
• Provide authority on risk-based assurance to IT, Quality, and business leadership.
• Ensure assurance decisions are evidence-based, defensible, and aligned with regulatory expectations.
• Engage senior stakeholders and guide regulatory interactions with a calm, governance-focused approach.

Skills

Technology assurance

Regulatory knowledge

Risk-based decision making

Leadership

Education

Bachelor's degree in IT/Engineering/Business

Advanced degree preferred

Tools

CSA framework

GxP QA standards

Regulatory guidelines (FDA, GAMP)

Job description

Kyowa Kirin North America is seeking a dynamic Director, IT Quality, Compliance and Technology Assurance to establish and govern the enterprise approach to technology assurance across GxP and non-regulated systems. You will own the CSA framework design, lead the CoE, and ensure risk-based, evidence-driven guidance for IT, Quality, and business leadership.

Responsibilities include defining assurance points, establishing governance, and partnering with regulatory stakeholders to maintain