Senior Director Device Quality

Bristol Myers Squibb • Madison, WI

13h • Hybrid

About The Position

The 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. The Senior Director 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. This role is a key strategic position within the R&D Quality Leadership Team.

Requirements

• 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.
• An 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 past 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.

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.
• Maintaining a governance program to enable the 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.
• Prepares budget submission for the Device Quality organization and prepares periodic projections of spending against budgets and manages and controls 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 in alignment and compliance with current BMS Corporate Compliance and current Global Quality Policies and Directives.
• Translate regulatory expectations into practical, risk‑based Device Quality oversight models.
• Interfaces with Regulatory Agencies as necessary, support and enable BMS internal sites and ExM CMOs in any relevant regulatory inspections and ensures 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.
• Ensuring 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.
• Leading 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.
• Notifies the appropriate levels of senior management in a timely manner of significant quality issues that have the potential to impact on patient safety, product supply, GxP compliance.
• Supports R&D, PD, BMS Site and ExM in preparation and reporting of defect reports, as appropriate to relevant Health Authorities.
• Participate in and management notification and health authority notification process and product recall / recovery, as appropriate, in accordance with BMS procedures.
• Ensure that all incoming personnel have adequate training, education and experience to perform their GxP relation job functions effectively.
• Partners with cross-functional teams across R&D and GBU to ensure that any issues impacting on product supply are acted on in a timely and proactive manner.
• 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.
• Ensure Quality Agreements clearly define roles, responsibilities, and escalation pathways.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior