Director – Diagnostic & Digital Health Quality Strategy
Bristol Myers Squibb
Princeton, NJ, United States
Base: $188,250 - $228,114; bonus/equity: not speci...
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Quality oversight strategies
Diagnostic and digital health vendors
Regulatory compliance
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Bristol Myers Squibb is seeking a Director for Diagnostic & Digital Health Quality Strategy to develop and implement quality oversight strategies within regulated environments for In Vitro Diagnostics and Digital Health. This role emphasizes collaboration with multiple internal and external stakeholders to ensure compliance with evolving regulations while enhancing quality management systems.
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Job Summary
Develop comprehensive internal and vendor quality oversight strategies for In Vitro Diagnostics (IVD), Companion Diagnostics (CDx), and Digital health assets within a regulated environment.
Serve as the primary Quality strategic partner to external diagnostic, CDx, SaMD, and digital health vendors, influencing quality expectations early in development lifecycles.
Utilizes Quality Risk Management (QRM) tools and innovative analytics/digital capabilities to achieve the optimal Quality Strategy in accordance with company objectives.
Matching Summary
Match Score: 75
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Bristol Myers Squibb is seeking a Director for Diagnostic & Digital Health Quality Strategy to develop and implement quality oversight strategies within regulated environments for In Vitro Diagnostics and Digital Health. This role emphasizes collaboration with multiple internal and external stakeholders to ensure compliance with evolving regulations while enhancing quality management systems.
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Salary
Base: $188,250 - $228,114; Bonus/Equity: Not specified; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits
Skills & Requirements
Must-have
Quality oversight strategies
Diagnostic and digital health vendors
Regulatory compliance
Quality Risk Management (QRM)
Vendor qualification audits
Inspection readiness
GCP, ISO, GLP, GMP regulations
Nice-to-have
Modernize quality practices
Partner engagement models
Continuous process improvements
Flexibility and open-mindedness
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
Expertise in diagnostic and digital health-specific audit execution
Demonstrated experience leading investigations and root cause analysis