Senior Director Device Quality
Bristol Myers Squibb
9 hours ago
Remote friendly (Princeton, NJ)
United States
Operations
Position Summary:
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/product lifecycle; serve as accountable quality leader across development, clinical, and commercial stages.
- Define and execute global Device Quality strategy aligned to enterprise objectives; maintain enterprise governance for GxP device activities.
- Partner with Precision Medicine, Clinical/ Product Development, Global Business Unit, and Regulatory Affairs on co-development, validation, approvals, and lifecycle management.
- Ensure compliance with global device/combination-product regulations (FDA, EMA, ICH, ISO); translate evolving expectations into risk-based oversight.
- Ensure CLIA/CAP/lab-standard compliance (data integrity, validation, change control, deviation management, inspection readiness).
- Own and continuously improve quality systems (design controls, risk management, supplier controls, complaints/vigilance, CAPA, post-market surveillance, laboratory quality).
- Lead Quality Council activities; notify senior management of significant quality issues; support defect reporting and recall/recovery processes.
- Own device quality system elements (SOPs, work instructions, controlled records) and drive continuous improvement.
- Embed ALCOA+ data integrity; drive risk identification/trending/mitigation using quality risk tools.
- Provide strategic supplier/external partner oversight (qualification, monitoring, audits, remediation) and ensure quality agreements.
Qualifications:
- Degree in science/engineering or related field; 10–12+ years progressive Quality leadership in medical devices/combination products.
- In-depth knowledge of global device/diagnostics regulatory requirements.
- Proven experience supporting device/combination product inspections/audits; strong interpretation of FDA/EMA and foreign cGxP.
- Strong communicator/collaborator; proven team leadership with coaching; leadership/strategic thinking/problem-solving and commitment to compliance/continuous improvement.
Compensation Overview (full-time):
- Devens, MA: $230,950–$279,861
- Madison, Giralda, Princeton, New Brunswick, NJ: $215,850–$261,558
- Additional incentive cash/stock may be available (eligibility-based).
Benefits (high level):
- Health coverage (medical/pharmacy/dental/vision); wellbeing support (EAP and well-being programs); financial protection (401(k), disability, life/accident/supplemental insurance, etc.); paid time off varies by location.
Application Instructions:
- If the role doesn’t perfectly match your resume, BMS encourages you to apply anyway.
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/product lifecycle; serve as accountable quality leader across development, clinical, and commercial stages.
- Define and execute global Device Quality strategy aligned to enterprise objectives; maintain enterprise governance for GxP device activities.
- Partner with Precision Medicine, Clinical/ Product Development, Global Business Unit, and Regulatory Affairs on co-development, validation, approvals, and lifecycle management.
- Ensure compliance with global device/combination-product regulations (FDA, EMA, ICH, ISO); translate evolving expectations into risk-based oversight.
- Ensure CLIA/CAP/lab-standard compliance (data integrity, validation, change control, deviation management, inspection readiness).
- Own and continuously improve quality systems (design controls, risk management, supplier controls, complaints/vigilance, CAPA, post-market surveillance, laboratory quality).
- Lead Quality Council activities; notify senior management of significant quality issues; support defect reporting and recall/recovery processes.
- Own device quality system elements (SOPs, work instructions, controlled records) and drive continuous improvement.
- Embed ALCOA+ data integrity; drive risk identification/trending/mitigation using quality risk tools.
- Provide strategic supplier/external partner oversight (qualification, monitoring, audits, remediation) and ensure quality agreements.
Qualifications:
- Degree in science/engineering or related field; 10–12+ years progressive Quality leadership in medical devices/combination products.
- In-depth knowledge of global device/diagnostics regulatory requirements.
- Proven experience supporting device/combination product inspections/audits; strong interpretation of FDA/EMA and foreign cGxP.
- Strong communicator/collaborator; proven team leadership with coaching; leadership/strategic thinking/problem-solving and commitment to compliance/continuous improvement.
Compensation Overview (full-time):
- Devens, MA: $230,950–$279,861
- Madison, Giralda, Princeton, New Brunswick, NJ: $215,850–$261,558
- Additional incentive cash/stock may be available (eligibility-based).
Benefits (high level):
- Health coverage (medical/pharmacy/dental/vision); wellbeing support (EAP and well-being programs); financial protection (401(k), disability, life/accident/supplemental insurance, etc.); paid time off varies by location.
Application Instructions:
- If the role doesn’t perfectly match your resume, BMS encourages you to apply anyway.