Director – Diagnostic & Digital Health Quality Strategy

Bristol Myers Squibb

Princeton, NJ, US
Base: $188,250 - $228,114; bonus/equity: + incenti...
Hybrid (50% onsite)
Ivd and cdx quality oversight strategy
Digital health vendor audit execution
Gcp iso glp gmp regulatory compliance
Bristol Myers Squibb is seeking a Director for Diagnostic & Digital Health Quality Strategy, responsible for developing oversight strategies for In Vitro Diagnostics and digital health assets. The role requires collaboration with various internal and external stakeholders to ensure compliance with evolving regulatory standards

Job Summary

  • This position will develop comprehensive internal and vendor quality oversight strategies for In Vitro Diagnostics, Companion Diagnostics, and Digital health assets within a regulated environment.
  • The role serves as a key collaborator across external partners and internal organizations to ensure fit-for-purpose, risk-based quality oversight aligned with the evolving global diagnostic landscape.
  • Bristol Myers Squibb offers competitive benefits including flexible time off, health coverage, and a supportive culture focused on transforming patients' lives through science.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Director for Diagnostic & Digital Health Quality Strategy, responsible for developing oversight strategies for In Vitro Diagnostics and digital health assets. The role requires collaboration with various internal and external stakeholders to ensure compliance with evolving regulatory standards.

Salary

Base: $188,250 - $228,114; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off, and wellbeing support programs

Skills & Requirements

Must-have

  • IVD and CDx quality oversight strategy
  • Digital health vendor audit execution
  • GCP ISO GLP GMP regulatory compliance
  • Third-party risk management activities
  • Root cause investigation leadership

Nice-to-have

  • Change leader to modernize quality practices
  • Strong negotiation and influence skills
  • Experience with PEARL assessments
  • Adaptability in rapidly changing environment
  • Business partnering capabilities

Key Requirements

  • Bachelor's degree in Life Sciences or Engineering
  • Experience in IVD, CDx, or SaMD sector
  • Deep expertise in software validation and data integrity
  • Knowledge of PEARL assessments and strategy room operations

Work Rights

Not specified

Tailored Resume

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