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 data to inform governance and decision‑making. Provide strategic oversight of device suppliers, contract manufacturers, testing laboratories, and service providers. Establish and maintain risk‑based supplier oversight models, including qualification, performance monitoring, audits, and remediation. Qualifications Educated to a degree level in science, engineering or related discipline with a minimum of 10‑12 years progressive experience in Quality leadership roles supporting medical devices and/or combination products. In‑depth knowledge of global regulatory requirements for medical devices and diagnostics. Proven experience supporting regulatory inspections and audits related to devices and combination products. Demonstrated proficiency in interpretation of FDA, EMA and foreign Health Authority cGxP regulations for medical devices and diagnostics. Proficient communicator and collaborator at a variety of levels and across divisions. Demonstrated success as a strong team leader who uses prior supervisory experience to develop departmental staff through effective feedback and coaching. Core competencies include leadership, strategic thinking, communication skills, teamwork, problem‑solving and a commitment to compliance and continuous improvement. Ability to build relationships cross‑functionally and influence internally/externally as appropriate. #J-18808-Ljbffr Jobtailor