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← Kyowa Kirin North America

Director, IT Quality, Compliance and Technology Assurance

Kyowa Kirin North America
Location
Princeton, New Jersey
Posted
1 month ago
Department
Information Technology
Salary
$185,000 to $220,000
What they actually want (must-haves)
  • Bachelor’s degree in Information Technology, Engineering, or Business field
  • At least 15 years’ experience in technology assurance, IT quality, validation, or related disciplines within regulated industries
  • Deep expertise in computer system validation (CSV), Computer Software Assurance (CSA), and risk-based assurance
  • Strong understanding of global regulatory expectations (e.g. FDA CSA guidance, GAMP, EU Annex 11)
  • Proven ability to design assurance frameworks and governance models
  • Strong grasp of modern IT delivery models, including COTS, SaaS, cloud platforms, and configurable systems
Nice to have
  • Advanced degree in Information Technology, Engineering field
What the job really is

The Director of IT Quality, Compliance and Technology Assurance at Kyowa Kirin will lead the global technology assurance strategy for both regulated and non-regulated systems. This role involves establishing a Computer Software Assurance framework, providing risk-based assurance leadership, and ensuring compliance with regulatory expectations. The director will also oversee the development of regional capabilities and act as a trusted advisor to senior leadership, balancing regulatory rigor with business needs.

Benefits
  • 401K with company match
  • Annual Bonus Program
  • Generous PTO and Holiday Schedule including 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
Things to weigh
  • Requires up to 10% domestic and international travel
  • No specific salary range mentioned, but a range of $185,000 to $220,000 is provided
  • Role involves significant leadership responsibilities in a regulated industry, which may require navigating complex compliance issues
Job score4.6/5
Benefits5/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency5/5

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