Bristol Myers Squibb
Principal Specialist, Quality Risk Management
Bristol Myers Squibb, Summit, New Jersey, us, 07902
Working with UsChallenging. 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.
At
Bristol Myers Squibb
we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
Position: Principal Specialist Quality Risk Management CAR T
Shift Available:
Monday - Friday, Hybrid Day Shift (8 a.m. - 5 p.m.)Responsibilities:
Evaluate and implement a plan to mitigate process and/or product risks and support cross-functional departments on risk identification, root cause analysis, and investigative measures.Contribute to the writing, coordination, review, approval, and maintenance of the S12 Risk Management Standard Operating Procedures (SOPs) and associated documentation.Develop and maintain documentation to track key risk information and provide risk reporting to include both quantitative and qualitative risk information.Evaluate and report key performance metrics, analyze data, and lead improvement initiatives.Facilitate planning, execution, and completion of risk assessments by providing direction and guidance to cross-functional teams.Ensure product risk management documentation/files are maintained, with good documentation practices and in compliance with S-12 Quality System.Partner with other risk management stakeholders, including Validation, Manufacturing, Quality Control, Patient Scheduling, Facilities, Warehouse, and Safety.Drive continuous improvement for effective risk management and to address recurring issues identified throughout S-12.Track and verify appropriate corrective actions have been implemented, documented, and align with source event.Maintain S12 Quality Risk Register and track the status of risk mitigation actions through to completion.Schedule and facilitate S-12 risk assessment activities to identify risk areas and implement risk mitigation measures to support manufacturing, compliance, and business continuity.Conduct risk reviews and escalate findings, as appropriate, to S12 Risk Management Leadership with resolution and recommendations.Represent the Risk Management unit at various project meetings and provide quality input in the resolution of quality-related issues.Work independently and perform with a high degree of accuracy.Apply Federal (FDA) Good Manufacturing Practice (GMP) requirements, guidelines, and documentation practices.Proactively learn, develop and customize methods and techniques (e.g. Six Sigma/Lean, FMEA, Root Cause Analysis, etc.) to improve effectiveness of the Risk Management program.Knowledge & Skills:
Experience and thorough understanding of risk management tools with in-depth knowledge of cGMPs and applicable FDA regulations guidelines and industry best practices.Proven experience working as a detailed-oriented team player with effective planning, organization, and execution skills.Experience with performing risk assessments using a variety of tools (e.g. FMEA, FTA, HACCP, etc.).Innovative, proactive, and resourceful; committed to quality and continuous improvement.Ability to work effectively at a fast pace with cross-functional departments to finalize time-sensitive deliverables.Able to manage multiple priorities.Strong computer skills with MS Office (e.g. Word, Visio, and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).Ability to make independent and objective decisions, and to work with minimal supervision.Must be able to interact with multidiscipline departments and Cell Therapy Development & Operations (CTDO) sites.Must possess an independent mindset and tenacity.Must be skilled in planning and organizing, coaching others, decision-making, and building relationships.Proficiency in developing reports and presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.Ability to work effectively across functional groups and teams to ensure requirements are met.Excellent verbal and communication skills.Basic Requirements:
Bachelor's degree in science required; advanced degree preferred.5 years of experience within the pharmaceutical or biotech industry.5 years within a Quality role.3-5 years of experience in Quality Risk Management in a cGMP/FDA regulated environment such as manufacturing/QC or QA.2-3 years of experience in change control.Preferred Requirements:
Experience in CAR T or Biologics preferred.Professional certification in Quality Risk Management preferred.Uniquely Interesting Work, Life-changing CareersWith 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.#J-18808-Ljbffr
At
Bristol Myers Squibb
we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
Position: Principal Specialist Quality Risk Management CAR T
Shift Available:
Monday - Friday, Hybrid Day Shift (8 a.m. - 5 p.m.)Responsibilities:
Evaluate and implement a plan to mitigate process and/or product risks and support cross-functional departments on risk identification, root cause analysis, and investigative measures.Contribute to the writing, coordination, review, approval, and maintenance of the S12 Risk Management Standard Operating Procedures (SOPs) and associated documentation.Develop and maintain documentation to track key risk information and provide risk reporting to include both quantitative and qualitative risk information.Evaluate and report key performance metrics, analyze data, and lead improvement initiatives.Facilitate planning, execution, and completion of risk assessments by providing direction and guidance to cross-functional teams.Ensure product risk management documentation/files are maintained, with good documentation practices and in compliance with S-12 Quality System.Partner with other risk management stakeholders, including Validation, Manufacturing, Quality Control, Patient Scheduling, Facilities, Warehouse, and Safety.Drive continuous improvement for effective risk management and to address recurring issues identified throughout S-12.Track and verify appropriate corrective actions have been implemented, documented, and align with source event.Maintain S12 Quality Risk Register and track the status of risk mitigation actions through to completion.Schedule and facilitate S-12 risk assessment activities to identify risk areas and implement risk mitigation measures to support manufacturing, compliance, and business continuity.Conduct risk reviews and escalate findings, as appropriate, to S12 Risk Management Leadership with resolution and recommendations.Represent the Risk Management unit at various project meetings and provide quality input in the resolution of quality-related issues.Work independently and perform with a high degree of accuracy.Apply Federal (FDA) Good Manufacturing Practice (GMP) requirements, guidelines, and documentation practices.Proactively learn, develop and customize methods and techniques (e.g. Six Sigma/Lean, FMEA, Root Cause Analysis, etc.) to improve effectiveness of the Risk Management program.Knowledge & Skills:
Experience and thorough understanding of risk management tools with in-depth knowledge of cGMPs and applicable FDA regulations guidelines and industry best practices.Proven experience working as a detailed-oriented team player with effective planning, organization, and execution skills.Experience with performing risk assessments using a variety of tools (e.g. FMEA, FTA, HACCP, etc.).Innovative, proactive, and resourceful; committed to quality and continuous improvement.Ability to work effectively at a fast pace with cross-functional departments to finalize time-sensitive deliverables.Able to manage multiple priorities.Strong computer skills with MS Office (e.g. Word, Visio, and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).Ability to make independent and objective decisions, and to work with minimal supervision.Must be able to interact with multidiscipline departments and Cell Therapy Development & Operations (CTDO) sites.Must possess an independent mindset and tenacity.Must be skilled in planning and organizing, coaching others, decision-making, and building relationships.Proficiency in developing reports and presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact.Ability to work effectively across functional groups and teams to ensure requirements are met.Excellent verbal and communication skills.Basic Requirements:
Bachelor's degree in science required; advanced degree preferred.5 years of experience within the pharmaceutical or biotech industry.5 years within a Quality role.3-5 years of experience in Quality Risk Management in a cGMP/FDA regulated environment such as manufacturing/QC or QA.2-3 years of experience in change control.Preferred Requirements:
Experience in CAR T or Biologics preferred.Professional certification in Quality Risk Management preferred.Uniquely Interesting Work, Life-changing CareersWith 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.#J-18808-Ljbffr