Bristol Myers Squibb
Healthcare
SeniorDirectorDeviceQuality
“Senior Director Device Quality at Bristol Myers Squibb. Skills: Device Quality, Regulatory Affairs, Quality Systems. Lead and advance Device Quality strategy. Serve as accountable quality leader”
What You'll Achieve.
Ensure patient safety; Ensure robust regulatory compliance; Ensure sustained inspection readiness
Industry & Context.
Root cause analysis; Risk-based oversight
What They're Looking For.
Must Have
5+ years quality experience, Experience with medical devices, Experience with combination products, Experience with companion diagnostics, Experience with diagnostic-enabled therapies, Experience with CLIA laboratory operations, Experience with FDA regulations, Experience with EMA regulations, Experience with ICH regulations, Experience with ISO regulations, Experience with CLIA, Experience with CAP, Experience with FDA CDx expectations, Experience with EU IVDR, Experience with global diagnostic regulations
Nice to Have
Master's degree preferred, Experience with precision medicine platforms preferred, Experience with cell therapy preferred
What You'll Do.
Lead and advance Device Quality strategy
Serve as accountable quality leader
Define and execute global Device Quality strategy
Maintain a governance program
Partner with cross-functional teams
Support co-development
Support regulatory approval
Support lifecycle management
Prepare budget submission
Prepare periodic projections
Manage and control department spending
Ensure compliance with global regulations
Interpret evolving regulatory expectations
Assess impact to device programs
Drive consistent application of Quality standards
Ensure alignment of GxP procedures
Translate regulatory expectations
Interface with Regulatory Agencies
Support regulatory inspections
Ensure compliance with filed requirements
Ensure compliance with laboratory standards
Oversee quality requirements for device development
Oversee quality requirements for tech transfer
Oversee quality requirements for commercialization
Oversee quality requirements for performance monitoring
Oversee quality requirements for post-market activities
Investigate deviations from procedures
Resolve deviations from procedures
Document deviations from procedures
Improve quality systems
Provide strategic quality oversight
Provide governance for laboratories
Lead Quality Council activities
Appraise senior leadership of GxP performance
Appraise senior network stakeholders of GxP performance
Notify senior management of quality issues
Support R&D in reporting defect reports
Support PD in reporting defect reports
Support BMS Site in reporting defect reports
Support ExM in reporting defect reports
Participate in notification process
Manage health authority notification process
Manage product recall
Manage product recovery
Ensure personnel have adequate training
Ensure personnel have adequate education
Ensure personnel have adequate experience
Act on issues impacting product supply
How You'll Work.
Team & Collaboration
Cross-functional teams; Precision Medicine teams; Clinical Development teams; Product Development teams; Global Business Unit teams; Regulatory Affairs teams; Global Manufacturing teams; External Manufacturing teams; Commercial teams; R&D teams; Quality Council activities
Communication Scope
Executive presentations
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