Senior Director Device Quality
Bristol Myers Squibb
9 days ago
Remote friendly (Devens, MA)
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).
Key Responsibilities
- Lead and advance the Device Quality strategy across the R&D and product lifecycle.
- Serve as accountable quality leader across development, clinical, and commercial stages.
- Define and execute global Device Quality strategy aligned to enterprise quality objectives.
- Maintain enterprise governance/oversight of all GxP Device activities.
- Partner with Precision Medicine, Clinical Development, Product Development, Global Business Unit, and Regulatory Affairs for co-development, validation, regulatory approval, and lifecycle management.
- Prepare Device Quality budget submissions and manage departmental spending.
- Ensure compliance with global device regulations/standards (FDA, EMA, ICH, ISO) and translate expectations into risk-based oversight.
- Ensure CLIA/CAP and global laboratory standard compliance (data integrity, method validation, change control, deviation management, inspection readiness).
- Oversee quality requirements for development, tech transfer, commercialization, performance monitoring, and post-market activities; investigate and document deviations.
- Own/continuously improve quality systems (design controls, risk management, supplier/external partner controls, complaints/vigilance, CAPA, post-market surveillance, laboratory quality systems).
- Lead Quality Council activities; manage notifications, health authority processes, and recall/recovery as needed.
Qualifications
- Degree in science, engineering, or related field.
- 10–12+ years progressive Quality leadership supporting medical devices and/or combination products.
- In-depth knowledge of global regulatory requirements for medical devices/diagnostics.
- Proven experience with regulatory inspections/audits.
- Demonstrated ability interpreting FDA/EMA and foreign cGxP regulations.
- Strong communication/collaboration; team leadership and coaching; leadership/strategic thinking/problem-solving.
Compensation & Benefits (explicit)
- Compensation ranges: Devens, MA $230,950–$279,861; Madison, NJ $215,850–$261,558; New Brunswick, NJ $215,850–$261,558; Princeton, NJ $215,850–$261,558.
- Benefits include medical/dental/vision; wellbeing support; 401(k); disability and life insurance.
Application Instruction
- If you’re intrigued but don’t perfectly match, encourage to apply anyway.
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).
Key Responsibilities
- Lead and advance the Device Quality strategy across the R&D and product lifecycle.
- Serve as accountable quality leader across development, clinical, and commercial stages.
- Define and execute global Device Quality strategy aligned to enterprise quality objectives.
- Maintain enterprise governance/oversight of all GxP Device activities.
- Partner with Precision Medicine, Clinical Development, Product Development, Global Business Unit, and Regulatory Affairs for co-development, validation, regulatory approval, and lifecycle management.
- Prepare Device Quality budget submissions and manage departmental spending.
- Ensure compliance with global device regulations/standards (FDA, EMA, ICH, ISO) and translate expectations into risk-based oversight.
- Ensure CLIA/CAP and global laboratory standard compliance (data integrity, method validation, change control, deviation management, inspection readiness).
- Oversee quality requirements for development, tech transfer, commercialization, performance monitoring, and post-market activities; investigate and document deviations.
- Own/continuously improve quality systems (design controls, risk management, supplier/external partner controls, complaints/vigilance, CAPA, post-market surveillance, laboratory quality systems).
- Lead Quality Council activities; manage notifications, health authority processes, and recall/recovery as needed.
Qualifications
- Degree in science, engineering, or related field.
- 10–12+ years progressive Quality leadership supporting medical devices and/or combination products.
- In-depth knowledge of global regulatory requirements for medical devices/diagnostics.
- Proven experience with regulatory inspections/audits.
- Demonstrated ability interpreting FDA/EMA and foreign cGxP regulations.
- Strong communication/collaboration; team leadership and coaching; leadership/strategic thinking/problem-solving.
Compensation & Benefits (explicit)
- Compensation ranges: Devens, MA $230,950–$279,861; Madison, NJ $215,850–$261,558; New Brunswick, NJ $215,850–$261,558; Princeton, NJ $215,850–$261,558.
- Benefits include medical/dental/vision; wellbeing support; 401(k); disability and life insurance.
Application Instruction
- If you’re intrigued but don’t perfectly match, encourage to apply anyway.