Bristol Myers Squibb
Senior 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.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.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.The Senior Specialist Quality Risk Management CAR T is responsible for supporting the S-12 Cell Therapy Quality Risk Management Program in accordance with BMS policies, standards, procedures and global cGMPs. The primary focus for this role is to facilitate the risk assessments, in order to identify risk areas and support implementing risk mitigation measures for S-12 operations, cGMP compliance and business continuity. Additionally, this role is responsible to maintain quality risk management program deliverables and facilitate complex cross-functional issue resolution by employing a methodical approach to root cause analysis and implementing appropriate corrective and preventive actions.Shift Available:Monday - Friday, Hybrid Day ShiftResponsibilities:The primary responsibilities of the Senior Specialist, Quality Risk Management are to evaluate and implement a plan to mitigate process and/or product risks and to 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 Catalog, Risk Register Registry 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: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 Operations (CTO) 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.Minimum 2 years' experience of Quality Risk Management in a cGMP/FDA regulated environment such as manufacturing/QC or QA.Minimum 3 years within a Quality role.Strong experience with risk management tools.
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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.The Senior Specialist Quality Risk Management CAR T is responsible for supporting the S-12 Cell Therapy Quality Risk Management Program in accordance with BMS policies, standards, procedures and global cGMPs. The primary focus for this role is to facilitate the risk assessments, in order to identify risk areas and support implementing risk mitigation measures for S-12 operations, cGMP compliance and business continuity. Additionally, this role is responsible to maintain quality risk management program deliverables and facilitate complex cross-functional issue resolution by employing a methodical approach to root cause analysis and implementing appropriate corrective and preventive actions.Shift Available:Monday - Friday, Hybrid Day ShiftResponsibilities:The primary responsibilities of the Senior Specialist, Quality Risk Management are to evaluate and implement a plan to mitigate process and/or product risks and to 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 Catalog, Risk Register Registry 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: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 Operations (CTO) 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.Minimum 2 years' experience of Quality Risk Management in a cGMP/FDA regulated environment such as manufacturing/QC or QA.Minimum 3 years within a Quality role.Strong experience with risk management tools.
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