• Job Description

  Req#: R1568168

  Working with Us
  Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

  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: careers.bms.com/working-with-us .

  The incumbent in this role will oversee the P roduct Qual ity Comp laint ( P QC) p rocess ing ac t i v ities including medical device/combination products, at P QC Head Quarters with a vision for continuous improvement and innovation including Robotic Process Automation (RPA), Artificial Intelligence (AI) and Machine Learning (ML).

  Roles and Responsibi l i ties

  • Provide subject matter expertise on the overall management of PQC process with focus on Medical Device/Combination products and post-market surveillance activities.

  • Lead PQC Signal Detection forums for GPS with robust outputs including reporting and escalation to various Quality Councils within Global Quality.

  • Lead associated PQC program activities including but not limited to review of complaint classifications, risk allocation, utilization of Quality Risk Management (QRM) principles in complaint category threshold determinations, trending, etc.

  • Support for WWPS survei l lan ce processes as appropriate by providing requested PQC data.

  • Ident ify and escalate any quality issues in the PQC process through appropr iate qual ity systems (Deviation, CAPA, Change Controls, etc) and as s i st in their review and approval.

  • Support upgrade activities related to bus i ness app li cat i ons such as S potfi re ( P Q C - M V T) and Infinity Dashboards.

  • Serve as SME for Device/Combination product complaints and execution of Medical Device Reporting (MDR) and Device Malfunction assessments

  • Partner with key stakeholders to enhance existing QMS in support of ISO 13485 certification for device/combination products and manage all aspects of quality systems, such as documentation, trainings, change controls, quality agreements and computer system validations as necessary for complaint handling

  • Participate in self-inspections and support requests from internal/external audits and regulatory inspections.

  • Support the PQC Community of Practice forums with collection of topics, content preparation and presentation.

  Key Requirements:

  • Mi n i mum of a Bachelor’s degree in Engineering, Health and/or Data Sciences r equ i red; Master’s degree, Biomedical E ngineer ing degree preferred; ASQ Certi f i cation in Qual ity Engineering (CQE) preferred.

  • Mi n imum of 10 y ears of experience within bio pharmac euti c al industry with at least 5 years working with medical device/combination products (21 CFR Part 4, EU MDR, ISO 13485).

  • Demonstrated leadership in Qual ity and/or Comp l iance di sc i p l ine w ith in-depth knowl edge of global applicable hea lth author i t y regul ations and requi rements. E x per i ence work ing wi th product qual i ty compl a i nts inv o l v i ng g lobal teams h i ghly des i rab le. People management expe r ience preferred.

  • Subject matter expertise in regulatory requirements for medical device/combination product complaint handling

  • Strong project management expertise and ability to focus on execution of strategic decisions while balance conflicting priorities.

  • Strong communication (written and verbal), leadership, influencing & negotiating and collaboration skills.

  • Demonstrated ability to make and act on decisions while balancing speed, quality and risks to the business within cross-matrix organization.

  #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.

  Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

• About the company

  BMS' primary R&D sites are located in Lawrence, New Jersey, New Brunswick, New Jersey, and Redwood City, California; with other sites in Devens and Cambridge, Massachusetts, East Syracuse, New York, Braine-l'Alleud, Belgium, Tokyo, Japan, Bangalore, In...

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