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
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 medical, dental, vision care, 401(k) plans, and flexible time off options to support work-life balance.
Matching 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.
Salary
Base: $188,250 - $228,114; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off
Skills & Requirements
Must-have
IVD and Companion Diagnostics quality strategy
Digital health vendor oversight experience
Regulatory compliance in GCP ISO GLP GMP
Risk-based audit execution and QRM tools
Inspection readiness and regulatory engagement
Nice-to-have
Change leadership in modernizing quality practices
Strong negotiation and stakeholder influence skills
Experience with PEARL assessments
Adaptability to rapidly changing environment
Business analysis for continuous process improvement
Key Requirements
Bachelor's degree in Life Sciences or Engineering
Experience in IVD, CDx, or SaMD sector quality management
Deep expertise in design controls and software validation
Demonstrated experience leading investigations and root cause analysis