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Position Summary:

As part of BMS Device and Combination Product Quality group, the employee in this role will be a key contributor on the R&ED Team. The individual in this position will have a complete understanding of a wide application of design control and risk management principles, theories, concepts, and has a full knowledge and/or expertise of application of these principles to In-Vitro Diagnostic devices. This position will be responsible for providing product development, packaging solutions, and engineering support by playing critical role in developing / integrating / analyzing / testing / and troubleshooting medical device/IVD components and systems relating to collection, preservation, preparation, distribution, testing and analysis of IVD components including their application to biological samples. This individual will provide solutions that are imaginative, thorough, and practical to a wide range of problems. The individual in this role will be the key point of contact for other quality functions as it relates to development of the product.

Key Responsibilities and Major Duties:

• Actively partner with operations and global audit teams to perform vendor audits to identify and implement improvement initiatives to address requirements with the European In-Vitro Diagnostic Device Regulation (IVDR), Medical Device Single Audit Program and ISO 13485.

• Act as quality assurance support for the design and development/on-market support of In-Vitro Diagnostics (IVD) medical device products, facilitating the application of design/change controls, risk management, quality plan, and implementation of design and development plan.

• Support the change control process by reviewing proposed changes, impact assessments, and assessing the adequacy of verifications and validations.

• Responsible Device Quality lead on medical device and IVD developmental teams including leading the quality related workstreams.

• Ownership of product level Quality Plans for invitro diagnostic devices.

• Quality lead for HA meetings and communications that are facilitated by Regulatory teams for products under development.

• Oversight of all quality activities that support introduction of IVD into Clinical trials (i.e., Quality Plan execution, Design Transfer into CLIA Lab (or similar), Creation and Execution of DMR etc).

• Collaborate with Operations teams to ensure that all Design Control and Design History File completed and translated into the DHF and are in compliance with Design Controls and the relevant elements of the Quality System Regulations

• Oversee the authoring of comprehensive quality system documents including quality manual, policies, directives, standard operating procedures and work instructions.

• Ensure risk management is executed through Risk Management Plans, Risk Files, Hazard analyses, and risk analyses e.g., dFMEA, pFMEA, uFMEA etc. throughout the life cycle of the product. Ensure management oversight of RM activities.

• Ensure the Design History File is complete by tracking deliverables and milestones.

• Provide internal or external training, as needed.

• Reviews and approves change control proposals as required, deviations, investigations, and corrective action/preventive action reports as part of quality support.

• Support evaluation of changes (component, product, process) prior to and post design transfer for impact on manufacturing process, documentation and design control elements.

• Serve as SME for evaluating the impact and applicability of new invitro diagnostic regulations via the PEARL process by overseeing activities performed by personnel.

Key Requirements:

• Minimum of a Bachelor of Science degree. A life science degree is preferred, e.g., Pharmacy, Chemistry, Biology, Engineering.

• Direct Quality unit responsibility for the development and technology transfer of IVDs.

• Minimum of 10 years' experience in IVD medical device product development in tissue typing (e.g., HLA, PCR) in a Quality, Technical, or Regulatory position or a combination thereof.

• A minimum of 5 years of CGMP/QSR audit experience in a support role.

• Direct experience in supporting IVD development teams and clinical trial implementation of IVDs.

• Experience in Quality System Regulation, IVDR (In Vitro Diagnostic Medical Device Regulation).

• Familiarity with FDA and EU regulation requirements associated with introducing IVDs into clinical trials.

• Familiarity with lab management requirements and notified body expectations for IVDs.

• Demonstrated experience leading and contributing through influence and working in cross functional teams to investigate and manage quality and compliance related issues.

• Knowledge in invitro diagnostic devices - design, development, and manufacturing, Quality Assurance, Validation, Verification, Specification setting, Technology Transfer, Supply Chain, and Packaging.

• In depth knowledge of Quality system principles and applications.

• Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.

#LI-Hybrid

If you come across a role that intrigues you but doesn’t 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.

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

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 adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

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

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