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

Role Summary

Senior Manager, QA Disposition Material Review Board at the Devens, MA Cell Therapy manufacturing facility. Leads the Material Review Board (MRB) process for non-conforming material in accordance with BMS policies and global cGMP. Acts as MRB Chair, coordinating with stakeholders to facilitate options for delivering Drug Product to patients across commercial and clinical manufacturing for cell therapy products.

Responsibilities

• Coordinate and prepare for Material Review Board (MRB) meetings
• Monitor quality events and impact assessments, supporting the MRB Coordinator for potentially non-conforming lots
• Review Pre-MRB Notifications and draft as needed; schedule MRB meetings and deliverables
• Oversee coordination and compilation of MRB content for presentation to senior leadership, medical affairs, legal, and other stakeholders
• Coordinate, co-author, and review Integrated Health Hazard Assessment (IHHA) documents as needed
• Chair MRB meetings and determine treatment options for patients using cross-functional analysis
• Author and approve MRB Executive Summaries with treatment options and meeting minutes
• Own and manage MRB outputs, action items, and quality records
• Record and manage MRB action items and approve MRB actions in electronic systems
• Manage MRB and material conversion business processes at the site, ensuring local and global policy compliance
• Provide support to the MRB Coordinator in material conversion execution
• 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
• Coach and train new MRB coordinators
• Support Disposition organization as needed

Qualifications

• Deep knowledge of internal policies and regulatory guidelines
• Proficient with MS Office, Smartsheets, and ability to learn new software
• Strong data interpretation, problem-solving, and documentation skills
• Experience reviewing investigation reports and challenging technical conclusions
• Excellent verbal and written communications; ability to present data to management
• Ability to work in a fast-paced team environment and lead cross-functional stakeholders
• Strategic thinking, deadline orientation, and prioritization skills
• Ability to influence cross-functional groups and network teams
• Ability to motivate and foster a positive team environment
• Decision-making confidence and proactive issue anticipation
• Curiosity and ability to create innovative solutions
• Experience handling protected health information
• FDA/EMA regulations experience in biopharmaceuticals or cell therapy manufacturing
• Proficiency with electronic systems and databases

Education

• Bachelor's degree in a STEM field preferred. High school diploma or Associate degree with equivalent experience may be considered
• 8+ years of experience in a regulated industry, with 4+ years in quality systems or lot disposition preferred