Bristol Myers Squibb
Healthcare
SeniorDirectorDeviceQuality
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“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
Full Job Description
**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: [careers.bms.com/working-with-us](https://careers.bms.com/working-with-us). **Position Summary** The Senior Director, Device Quality provides global strategic leadership and accountability for Quality across medical devices, drug device combination products, companion diagnostics (CDx), and precision medicine–enabling platforms, including CLIA certified laboratory operations supporting clinical trials and commercial diagnostics. This role ensures patient safety, robust regulatory compliance, and sustained inspection readiness across the full lifecycle—from early development through commercialization and post market surveillance. The Senior Director partners closely with Precision Medicine, R&D, Clinical Development, Regulatory Affairs, Global Manufacturing, External Manufacturing, and Commercial teams to embed quality by design into innovative, personalized medicine solutions. This role is a key strategic position within the R&D Quality Leadership Team. _**Key Responsibilities** Device Quality Leadership & Strategy_ * Lead and advance the Device Quality strategy across the R&D and product lifecycle
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