Senior Director, Device Quality

Responsibilities

• Lead and advance the Device Quality strategy across the 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 prepare periodic projections of spending against budgets and manage and control department spending.
• Ensure compliance with global regulations and standards applicable to medical devices and combination products (e.g., FDA, EMA, ICH, ISO).
• Interpret evolving regulatory expectations and proactively assess impact to device programs and platforms.
• Drive consistent application of Quality standards across development, transfer, manufacturing, and post‑market activities.
• Ensure relevant global GxP procedures for devices are aligned and compliant with current BMS Corporate Compliance and current Global Quality Policies and Directives.
• Translate regulatory expectations into practical, risk‑based Device Quality oversight models.
• Interface with Regulatory Agencies as necessary, support and enable BMS internal sites and ExM CMOs in any relevant regulatory inspections and 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.
• Ensure compliance with applicable global regulatory frameworks, including FDA CDx expectations, EU IVDR, and relevant international diagnostic regulations.
• Oversee quality requirements for device development, tech transfer, commercialization, performance monitoring, and post‑market activities.
• Ensure that deviations from procedures and specifications are investigated, resolved and documented.
• Own and continuously improve quality systems supporting:
  Design controls, Risk management, Supplier and external partner controls, Complaint handling and vigilance, CAPA and post‑market surveillance, Laboratory quality systems to assure a state of health authority inspection readiness of device portfolio.
• Provide strategic quality oversight and governance for CLIA CAP laboratories supporting clinical trial testing, biomarker analysis, and diagnostic development.
• Lead Quality Council activities for Device Quality related topics ensuring that senior leadership and senior network stakeholders are appraised of GxP performance, and any risks to BMS compliance status.
• Notify appropriate levels of senior management in a timely manner of significant quality issues that may impact patient safety, product supply, GxP compliance.
• Support R&D, PD, BMS Site and ExM in preparation and reporting of defect reports, as appropriate to relevant Health Authorities.
• Ensure that all incoming personnel have adequate training, education and experience to perform their GxP related job functions effectively.
• Partner with cross‑functional teams across R&D and GBU to ensure that any issues impacting product supply are acted on timely and proactively.
• Own and oversee Device Quality‑related Quality System elements, including SOPs, work instructions, and controlled records.
• Ensure design control, risk management, verification/validation, and lifecycle documentation meet regulatory and inspection expectations.
• Drive continuous improvement of Device Quality processes and systems.
• Ensure ALCOA+ data integrity principles are embedded into device development, testing, and manufacturing processes.
• Drive proactive risk identification, trending, and mitigation using structured Quality risk management tools.
• Use Quality metrics and trend…