Senior Director Device Quality

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Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives. Read more: Summary

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 medicineenabling 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 lifecyclefrom 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.

Key Responsibilities
Device Quality Leadership & Strategy

• 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 diagnosticenabled 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 codevelopment 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.

GxP Compliance & Regulatory Oversight

• 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 postmarket 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 riskbased 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 postmarket 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 postmarket 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.

Governance Cross Functional Collaboration & Representation

• 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.

Quality Systems & Documentation

• Own and oversee Device Qualityrelated 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.

Data Integrity & Risk Management

• 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 decisionmaking.

Supplier & External Partner Quality Oversight

• Provide strategic oversight of device suppliers contract manufacturers testing laboratories and service providers.

• Establish and maintain riskbased supplier oversight models including qualification performance monitoring audits and remediation.

• Ensure Quality Agreements clearly define roles responsibilities and escalation pathways.

Qualifications & Experience

• 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.

#LI-Hybrid

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Devens - MA - US: $230950 - $279861 Madison - Giralda - NJ - US: $215850 - $261558 New Brunswick - NJ - US: $215850 - $261558 Princeton - NJ - US: $215850 - $261558

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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.

*Eligibility Disclosure: T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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