Principal Specialist, Quality Risk Management

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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 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.

Shift Available:

• Monday - Friday, Hybrid Day Shift (8 a.m. - 5 p.m.)

Responsibilities:

• 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 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 independ