Senior Manager, QA Disposition Material Review Board in Devens, MA

Senior Manager, QA Material Review Board

Working with Us Challenging. 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. 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 Manager, QA Material Review Board role is responsible for the Material Review Board (MRB) process for non-conforming material at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP.

They will oversee atypical events to ensure the appropriate management notifications occur per procedure. This individual will coordinate with stakeholders to gather supporting documentation and content for the Material Review Boards to facilitate options for delivering Drug Product to patients. The primary stakeholders for this role are QA Disposition, QA / QC / MST Investigations, Medical, Legal, senior site leadership, and other product level teams. This individual will act as MRB Chair, ensure accurate and timely MRB facilitation and follow up, including material conversion, maintenance and review of SOPs, and acts as primary point of contact for MRB.

Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Devens.

Shifts Available : M-F, Standard Working Hours

Responsibilities :

• Coordinate and prepare for Material Review Board (MRB) meetings by :
• Monitoring quality events and impact assessments, supporting the MRB Coordinator as needed, for potentially non conforming lots.
• Review Pre-MRB Notification sent to Management and MRB Stakeholders, and draft as needed to support the MRB Coordinator. Scheduling MRB meetings and deliverables as needed.
• Oversee / Review coordination and compilation of Material Review Board (MRB) content for presentation to senior leadership, medical affairs, legal, and other program stakeholders as it relates to potentially non conforming lots during the manufacture or testing of Cell Therapy Drug Products.
• Co-authoring, and review of Integrated Health Hazard Assessment (IHHA) documents as needed.
• Chair MRB meetings and determining available treatment options for patients, leveraging cross functional analysis by stakeholders
• Author as needed, and approve MRB Executive Summary with available treatment options and meeting minutes.
• Own and manage MRB outputs, action items, and Quality records.
• Record and manage MRB action items and approve MRB Record actions in electronic system.
• Own and manage MRB and material conversion business processes at the manufacturing site by assuring local compliance with applicable BMS Policies, Guidelines, and Directives and ensuring consistency with site and global procedures and / or specifications.
• Provide support, as needed, to the MRB Coordinator in execution of Material Conversion activities.
• Drive improvement initiatives related to MRB and Material Conversion.
• Act as subject matter expert and present MRB and Material Conversion program overviews during inspections and audits.
• Coaching and training new MRB coordinators.
• Support Disposition organization as needed.

Knowledge and Skills :

Basic Requirements :

Compensation Overview : Devens - MA - US : $130,020 - $157,559