Senior Director Device Quality
Bristol Myers Squibb
6 days ago
Remote friendly (Madison, NJ)
United States
Operations
Position: Senior Director, Device Quality (R1602966)
Responsibilities
- Lead and advance the global Device Quality strategy across the R&D and product lifecycle; accountable quality leader for medical devices, drug-device combination products, companion diagnostics, and diagnostic-enabled therapies.
- Define and execute strategy aligned with enterprise quality objectives; maintain enterprise governance/monitoring for GxP device activities.
- Partner with Precision Medicine, Clinical Development, Product Development, Regulatory Affairs, Global/External Manufacturing, and Commercial teams to support co-development, validation, regulatory approval, and lifecycle management.
- Ensure compliance with global medical device/combination product regulations and standards (FDA, EMA, ICH, ISO); translate expectations into risk-based oversight.
- Oversee quality across development, tech transfer, commercialization, performance monitoring, and post-market activities; investigate/resolve/document deviations.
- Own and continuously improve quality systems (design controls, risk management, supplier/external partner controls, complaint handling/vigilance, CAPA, post-market surveillance, laboratory quality).
- Lead governance/collaboration activities, quality council topics, health authority/recall processes, and training readiness.
Qualifications & Skills
- Degree in science/engineering or related field; 10–12+ years progressive quality leadership in medical devices/combination products.
- In-depth knowledge of global device and diagnostic regulatory requirements; proven experience with inspections/audits; strong FDA/EMA and foreign health authority cGxP interpretation.
- Leadership, strategic thinking, communication, teamwork, problem-solving; commitment to compliance/continuous improvement; cross-functional relationship building.
Compensation & Benefits
- Starting base pay ranges (US): $230,950–$279,861 (Devens, MA); $215,850–$261,558 (Madison/New Brunswick/Princeton, NJ). Additional incentive may be available.
- Benefits include medical/pharmacy/dental/vision, wellbeing support, 401(k), disability and life insurance.
On-site Protocol
- Site-essential: 100% onsite; Site-by-design: at least 50% onsite; field/remote-by-design: ability to travel as required.
Application instructions
- If intrigued but not perfectly aligned, apply anyway.
Responsibilities
- Lead and advance the global Device Quality strategy across the R&D and product lifecycle; accountable quality leader for medical devices, drug-device combination products, companion diagnostics, and diagnostic-enabled therapies.
- Define and execute strategy aligned with enterprise quality objectives; maintain enterprise governance/monitoring for GxP device activities.
- Partner with Precision Medicine, Clinical Development, Product Development, Regulatory Affairs, Global/External Manufacturing, and Commercial teams to support co-development, validation, regulatory approval, and lifecycle management.
- Ensure compliance with global medical device/combination product regulations and standards (FDA, EMA, ICH, ISO); translate expectations into risk-based oversight.
- Oversee quality across development, tech transfer, commercialization, performance monitoring, and post-market activities; investigate/resolve/document deviations.
- Own and continuously improve quality systems (design controls, risk management, supplier/external partner controls, complaint handling/vigilance, CAPA, post-market surveillance, laboratory quality).
- Lead governance/collaboration activities, quality council topics, health authority/recall processes, and training readiness.
Qualifications & Skills
- Degree in science/engineering or related field; 10–12+ years progressive quality leadership in medical devices/combination products.
- In-depth knowledge of global device and diagnostic regulatory requirements; proven experience with inspections/audits; strong FDA/EMA and foreign health authority cGxP interpretation.
- Leadership, strategic thinking, communication, teamwork, problem-solving; commitment to compliance/continuous improvement; cross-functional relationship building.
Compensation & Benefits
- Starting base pay ranges (US): $230,950–$279,861 (Devens, MA); $215,850–$261,558 (Madison/New Brunswick/Princeton, NJ). Additional incentive may be available.
- Benefits include medical/pharmacy/dental/vision, wellbeing support, 401(k), disability and life insurance.
On-site Protocol
- Site-essential: 100% onsite; Site-by-design: at least 50% onsite; field/remote-by-design: ability to travel as required.
Application instructions
- If intrigued but not perfectly aligned, apply anyway.