Bristol Myers Squibb

Healthcare

SeniorDirectorDeviceQuality

$231–280k United States FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“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.

Healthcare
Problems you'll solve

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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