Director, Device Quality Management & Compliance

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science.In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Reporting to the Sr. Dir, Device & Combination Product Quality, the Director of Device Quality Management & Compliance is responsible for the maintenance and continuous improvement of the BMS device and combination product Quality Management System elements including the Quality Manual, Quality Plan and all associated device and combination product specific processes and procedures. The Director is a key senior leader within the broader Global Quality Systems (GQS) team and is the primary SME for the device and combination product quality system internally and externally (inspections and audits). This position is also a people manager and will have direct reports.

Role Responsibilities:

• Own and maintain the Combination Product Quality Manual

• Own and execute the quarterly Tier 2 Device Quality Council inclusive of analysis and preparation of materials.

• Collaborate with the Quality Council Global Process Owner and peer Quality Council owners to ensure seamless flow of information and appropriate/timely escalation of critical issues.

• Own and maintain the master training and development strategy for device and combination products across the Enterprise (working in collaboration with key cross-functional partners).

• Own and Implement critical QMS continuous improvement initiatives including the evolution of the BMS E2E QMS to obtain device QMS certification.

• Core contributor to inspection readiness across the BMS network relative to device and combination products.

• Core contributor to Culture of Excellence initiatives relative to Device & Combination Product Quality.

• Partner with E2E QMS process owners (CAPA, Deviation, Design Control, etc..) to ensure seamless execution of device and combination product operations.

• Partner with Companion Diagnostics (CDx) and Digital Therapeutics (DTx) to ensure the device and combination QMS meets the needs of key pipeline programs and capabilities.

• Provide front and back room support for global health authority and regulatory inspections as device and combination product QMS subject matter expert.

• Continuously develop and provide mobility for leaders within BMS while ensuring a robust pipeline of talent and succession planning.

• Ability to travel up to 25% globally (including global site inspections as needed).

Role Requirements:

• Minimum BS in life sciences including engineering (mechanical, biomedical and/or systems) and natural/physical science (chemistry, biology, and biochemistry). Minimum 10 years relevant work experience, specifically in the regulated healthcare space preferably within medical device or combination products. Minimum 5 years of leadership experience.

• Expert knowledge of device and combination product regulations/standards including 21 CFR Part 820, Part 3, Part 4, ISO13485, ISO1497 and MDR2021 (IVDR2022 a plus).

• Awareness of pharmaceutical and biologic regulations and standards including 21 CFR Part 210, 21 CFR part 600, 2010/83/EC and relevant ICH guidelines.

• Knowledge of continuous improvement methodologies and practices including Lean and Six Sigma.

• Demonstrated prior experience with regulators including back and front room inspection experience is REQUIRED.

• Prior experience in the implementation of an ISO13485 compliant QMS, including final certification, is highly valuable.

• Demonstrated knowledge of Quality Risk Management (QRM) processes and strategies (in alignment with ISO14971) is REQUIRED.

• Prior experience in the implementation of inspection readiness programs at both corporate and manufacturing locations is highly valuable.

• Prior experience with quality culture of excellence program implementation also highly desirable.

#LI-Hybrid

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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