Manager, Quality Assurance Investigations, Cell Therapy

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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 Manager, QA Investigations, is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Devens Cell Therapy Facility. The role provides Quality oversight and assurance of the quality of manufactured products, in compliance with all applicable regulations and BMS policies and guidelines.

Shifts Available:

TBD

Responsibilities:

• Review and approve complex investigations/ CAPAs / effectiveness checks associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems.
• Author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program.
• Ensure the corrective/ preventive actions are robust and adequately address the root cause.
• May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.
• Drive deployment of effective deviation processes within representative site/function.
• Coach employees on aspects of investigations.
• Resolve investigational process or system issues.
• Ensure appropriate issues are cascaded to global team and liaise with global team on routine basis.
• Provide relevant monitoring of functional area deviation metrics.
• Champion for culture of quality within the deviation program.
• Proactively monitor metrics and take relevant actions (including work prioritization) to ensure that disposition timelines and other targets are met.
• Identifies improvement opportunities and drives execution of site/team continuous improvement goals and projects.
• Support internal and external inspections as required.
• May present individual topics during audits as needed.
• Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams.
• Support integration of newer team members
• Acts as Subject Matter Expert of the root cause analysis and investigations process and provides guidance/ coaching to less experienced staff with atypical events during day-to-day operations.
• Lead meetings and represent function at cross functional and network meetings.

Knowledge, Skills, Abilities:

• Ability to research, understand, interpret and apply internal policies and regulatory guidelines.
• Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheets etc. and ability to learn and work with new software applications.
• Demonstrated experience to interpret complex data & results, understand significant problems with multiple variables and critically assess and provide feedback on proposed CAPA.
• Demonstrated experience to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles.
• Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy.
• Ability to work in a fast-paced team environment and lea