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

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. Read more: careers.bms.com/working-with-us.

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.
• Coordinating, 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:

• 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
• Advanced ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation.
• Ability 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 advanced ability to prepare written communications and present complex technical data to management with clarity and accuracy
• Ability to work in a fast-paced team environment and lead team and cross-functional stakeholders through changing priorities.
• Ability to think strategically, meet deadlines and prioritize work.
• Able to independently work across and influence cross-functional groups and network teams to ensure requirements are met.
• Ability to motivate and foster a positive team environment
• Confident in making decisions, able to anticipate Quality issues and proactively solve problems
• Curious and ability to think critically to create innovative solutions
• Experience working with protected health information
• Demonstrated experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
• Demonstrated proficiency with electronic system and databases

Basic Requirements:

• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 8+ years of experience in a regulated industry, preferably with 4+ year of quality system or lot disposition experience.

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Compensation Overview:

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


The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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