Director – Diagnostic & Digital Health Quality Strategy

Bristol Myers Squibb UK

Princeton, NJ, United States
Base: $188,250 - $228,114; bonus/equity: + incenti...
On-site
Internal and vendor quality oversight
Diagnostic and digital health regulatory landscape
Qms processes and oversight
Bristol Myers Squibb is seeking a Director of Diagnostic & Digital Health Quality Strategy to develop and implement quality oversight strategies for diagnostics and digital health assets. The ideal candidate will have extensive experience in quality management within a regulated environment, focusing on in vitro diagnostics and digital health, and will play a pivotal role in collaborating with internal and external stakeholders

Job Summary

  • This position will develop comprehensive internal and vendor quality oversight strategies for In Vitro Diagnostics (IVD), Companion Diagnostics (CDx), and Digital health assets within a regulated environment.
  • The Director will serve as a key collaborator across external partners, internal R&D, Regulatory, Clinical, IT/Digital, and Quality organizations, ensuring fit-for-purpose, risk-based quality oversight aligned with a rapidly evolving global diagnostic and digital health regulatory landscape.
  • Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Director of Diagnostic & Digital Health Quality Strategy to develop and implement quality oversight strategies for diagnostics and digital health assets. The ideal candidate will have extensive experience in quality management within a regulated environment, focusing on in vitro diagnostics and digital health, and will play a pivotal role in collaborating with internal and external stakeholders.

Salary

Base: $188,250 - $228,114; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Paid Time Off

Skills & Requirements

Must-have

  • internal and vendor quality oversight
  • diagnostic and digital health regulatory landscape
  • QMS processes and oversight
  • global audit strategy
  • vendor quality oversight
  • inspection readiness
  • regulatory intelligence

Nice-to-have

  • quality risk management tools
  • innovative analytics and digital capabilities
  • business analysis for process improvements
  • flexibility and adaptability

Key Requirements

  • Bachelor’s degree in Life Sciences, Engineering, or related field
  • Experience in quality management, vendor oversight, and audit strategy in IVD, CDx, or SaMD sector
  • Deep expertise in diagnostic and digital health-specific audit execution
  • Comprehensive knowledge of GCP, ISO, GLP, GMP relevant regulatory requirements
  • Demonstrated experience leading investigations and root cause analysis

Work Rights

Not specified

Tailored Resume

Cover Letter