Senior Director Device Quality

Position Summary

The Senior Director, Device Quality provides global strategic leadership and accountability for quality across medical devices, drug device combination products, companion diagnostics, precision medicine enabling platforms, and CLIA‑certified laboratory operations supporting clinical trials and commercial diagnostics.

Role ensures patient safety, regulatory compliance, and inspection readiness throughout development, commercialization, and post‑market surveillance. 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.

• Lead and advance the Device Quality strategy across R&D and product lifecycle.
• Serve as the accountable quality leader for medical devices, combination products, companion diagnostics and diagnostic‑enabled therapies across development, clinical, and commercial stages.
• Define and execute the global Device Quality strategy aligned with BMS enterprise quality objectives and business priorities.
• Maintain a governance program to enable oversight and monitoring of all GxP Device‑related activities at an enterprise level.
• Partner closely with Precision Medicine, Clinical Development, Product Development, Global Business Unit, and Regulatory Affairs to support co‑development, validation, regulatory approval and lifecycle management of diagnostics and devices.
• Prepare budget submission for the Device Quality organization and manage departmental spending.

• Ensure compliance with FDA, EMA, ICH, ISO and other global regulations and standards applicable to medical devices and combination products.
• Interpret evolving regulatory expectations and proactively assess impact to device programs and platforms.
• Apply quality standards consistently across development, transfer, manufacturing and post‑market activities.
• Align global GxP procedures with BMS corporate compliance and global quality policies and directives.
• Translate regulatory expectations into risk‑based Device Quality oversight models.
• Interface with regulatory agencies, support and enable BMS internal sites and ExM CMOs during inspections to ensure compliance with filed regulatory requirements.
• Ensure compliance with CLIA, CAP and applicable global laboratory standards including data integrity, method validation, change control, deviation management and inspection readiness.
• Oversee quality requirements for device development, tech transfer, commercialization, performance monitoring and post‑market activities.
• Investigate, resolve and document deviations from procedures and specifications.
• Own and continuously improve quality systems supporting design controls, risk management, supplier/control, complaint handling and vigilance, CAPA, post‑market surveillance and laboratory quality systems.
• Provide strategic quality oversight and governance for CLIA CAP laboratories supporting clinical trial testing, biomarker analysis and diagnostic development.

• Lead Device Quality Council activities and keep senior leadership and stakeholders informed of GxP performance and risks.
• Notify senior management promptly of quality issues that could impact patient safety, product supply or GxP compliance.
• Participate in notification and health‑authority processes for recall/recovery per BMS procedures.
• Ensure incoming personnel receive adequate training, education and experience for GxP‑related jobs.
• Partner with cross‑functional teams to act on issues impacting product supply.

• Own and oversee Device Quality‑related quality systems, SOPs, work instructions and controlled records.
• Ensure design control, risk management, verification/validation and lifecycle documentation meet regulatory expectations.
• Drive continuous improvement of Device Quality processes and systems.

• Embed ALCOA+ data integrity principles into device development, testing and manufacturing processes.
• Drive proactive risk identification, trending…