Senior Director Device Quality
Bristol Myers Squibb
8 days ago
Remote friendly (Madison, NJ)
United States
Operations
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).
Responsibilities
- Lead and advance Device Quality strategy across the R&D and product lifecycle; accountable quality leader across development, clinical, and commercial stages.
- Define/execute global Device Quality strategy aligned to enterprise objectives; maintain enterprise GxP governance for device activities.
- Partner with Precision Medicine, R&D, Clinical Development, Regulatory Affairs, Global/External Manufacturing, and Commercial to embed quality by design; support co-development, validation, regulatory approval, and lifecycle management.
- Ensure compliance with global device regulations/standards (e.g., FDA, EMA, ICH, ISO); interpret evolving expectations and translate into risk-based oversight.
- Ensure CLIA/CAP and laboratory standards compliance (data integrity, method validation, change control, deviations, inspection readiness) and frameworks for CDx/IVDR.
- Own and improve quality systems (design controls, risk management, supplier/external partner controls, complaint handling/vigilance, CAPA, post-market surveillance, lab quality).
- Lead Quality Council activities; notify senior management of significant quality issues; support defect reporting, health authority notifications, and product recall/recovery.
- Oversee device quality systems/documentation; drive continuous improvement; embed ALCOA+ and quality risk management.
Qualifications
- Degree in science/engineering/related field.
- 10–12+ years progressive quality leadership experience supporting medical devices/combination products.
- In-depth global regulatory knowledge; proven experience with regulatory inspections/audits; strong FDA/EMA and foreign cGxP interpretation.
Compensation (US locations)
- Devens, MA: $230,950–$279,861; Madison/Giralda, NJ: $215,850–$261,558; New Brunswick, NJ: $215,850–$261,558; Princeton, NJ: $215,850–$261,558.
- Additional incentive cash/stock may be available (based on eligibility).
Benefits (high level)
- Health coverage; wellbeing support; 401(k), disability, life/accident insurance, supplemental health, travel protection, legal support.
Application
- If the posting is missing required/incorrect info, contact TAEnablement@bms.com with the job title and requisition number; status inquiries directed to “Chat with Ripley”.
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).
Responsibilities
- Lead and advance Device Quality strategy across the R&D and product lifecycle; accountable quality leader across development, clinical, and commercial stages.
- Define/execute global Device Quality strategy aligned to enterprise objectives; maintain enterprise GxP governance for device activities.
- Partner with Precision Medicine, R&D, Clinical Development, Regulatory Affairs, Global/External Manufacturing, and Commercial to embed quality by design; support co-development, validation, regulatory approval, and lifecycle management.
- Ensure compliance with global device regulations/standards (e.g., FDA, EMA, ICH, ISO); interpret evolving expectations and translate into risk-based oversight.
- Ensure CLIA/CAP and laboratory standards compliance (data integrity, method validation, change control, deviations, inspection readiness) and frameworks for CDx/IVDR.
- Own and improve quality systems (design controls, risk management, supplier/external partner controls, complaint handling/vigilance, CAPA, post-market surveillance, lab quality).
- Lead Quality Council activities; notify senior management of significant quality issues; support defect reporting, health authority notifications, and product recall/recovery.
- Oversee device quality systems/documentation; drive continuous improvement; embed ALCOA+ and quality risk management.
Qualifications
- Degree in science/engineering/related field.
- 10–12+ years progressive quality leadership experience supporting medical devices/combination products.
- In-depth global regulatory knowledge; proven experience with regulatory inspections/audits; strong FDA/EMA and foreign cGxP interpretation.
Compensation (US locations)
- Devens, MA: $230,950–$279,861; Madison/Giralda, NJ: $215,850–$261,558; New Brunswick, NJ: $215,850–$261,558; Princeton, NJ: $215,850–$261,558.
- Additional incentive cash/stock may be available (based on eligibility).
Benefits (high level)
- Health coverage; wellbeing support; 401(k), disability, life/accident insurance, supplemental health, travel protection, legal support.
Application
- If the posting is missing required/incorrect info, contact TAEnablement@bms.com with the job title and requisition number; status inquiries directed to “Chat with Ripley”.