Senior Director Device Quality

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 supporting clinical trials and commercial diagnostics. This role ensures patient safety, robust regulatory compliance, and sustained inspection readiness across the full lifecycle— from early development through commercialization and post‑market surveillance. Key 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, aligning with BMS enterprise quality objectives and business priorities. Maintain a governance program to monitor all GxP Device-related activities at an enterprise level. Partner 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 submissions for the Device Quality organization and manage departmental 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 assess impact on 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 with current BMS Corporate Compliance and Global Quality Policies. Translate regulatory expectations into practical, risk‑based Device Quality oversight models. Interface with Regulatory Agencies as needed, support and enable BMS internal sites and ExM CMOs in regulatory inspections, and ensure compliance with filed regulatory requirements. Ensure compliance with CLIA, CAP, and other 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 and external partner controls, complaint handling, 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 Quality Council activities for Device Quality topics, ensuring senior leadership and stakeholders are apprised of GxP performance and risks. Notify senior management of significant quality issues that could impact patient safety, product supply, or GxP compliance. Support R&D, PD, BMS Site, and ExM in defect reporting, health authority notification, product recall/recovery, and other regulatory processes. Ensure incoming personnel are adequately trained and experienced for their GxP roles. Partner with cross‑functional teams across R&D and GBU to address issues impacting product supply promptly. Own and oversee Device Quality–related Quality System elements such as SOPs, work instructions, and controlled records. Drive continuous improvement of Device Quality processes and systems. Embed ALCOA+ data integrity principles into device development, testing, and manufacturing processes. Use structured quality risk‑management tools to identify and mitigate risks, and inform governance and decision‑making. Provide strategic oversight of device suppliers, contract manufacturers, testing laboratories, and service providers, establishing risk‑based supplier oversight models. Ensure Quality Agreements clearly define roles, responsibilities, and escalation pathways. Qualifications & Experience Degree level in science, engineering, or related discipline. 10‑12 years of 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 interpreting FDA, EMA, and foreign Health Authority cGxP regulations for medical devices and diagnostics. Proficient communicator and collaborator across multiple levels and divisions. Success as a strong team leader, using supervisory experience to develop departmental staff through effective feedback and coaching. Core competencies: leadership, strategic thinking, communication, teamwork, problem‑solving, and commitment to compliance and continuous improvement. Ability to build cross‑functional relationships and influence both internally and externally. Compensation & Benefits Compensation ranges: Devens, MA: $230,950 – $279,861 Madison, NJ: $215,850 – $261,558 New Brunswick, NJ: $215,850 – $261,558 Princeton, NJ: $215,850 – $261,558 Additional incentive cash and stock opportunities may be available. For detailed benefits information, visit the BMS careers website. Equal Employment Opportunity BMS is an equal‑opportunity employer. Individuals with disabilities are encouraged to apply as the organization supports reasonable accommodations. #J-18808-Ljbffr