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PURPOSEAND SCOPE OF POSITION:
The Principal 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 implement 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.
As a member of the Quality Assurance Organization, this position is working closely with the S-12 Quality Risk Management leadership and other company risk management stakeholders, to identify and provide solutions to cGMP related issues and escalate them as appropriate to ensure the site remains in a state of control.
The primary responsibilities of the Principal 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.
REQUIREDCOMPETENCIES: Knowledge, Skills, and Abilities:
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.
Bachelor’s degree in Science required; advanced degree preferred.
Minimum 7 years’ experience of Quality Risk Management in a cGMP/FDA regulated environment such as manufacturing/QC or QA.
Experience in CAR T or Biologics preferred.
Professional certification in Quality Risk Management preferred.
Equivalent combination of education and experience acceptable.
Internal Number: R1530633
About Bristol Myers Squibb
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.