Manager, Quality Assurance Disposition Support, Cell Therapy

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 rich in diversity. 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.

Position Summary
The Manager, Quality Assurance Disposition Support, Devens Cell Therapy role is responsible for the support of the overall Devens Disposition organization, inclusive of systems, metrics, Quality System Records, and deployment of priority projects.

This individual will provide support to all functions reporting through the Quality Disposition organization, including incoming materials QA and disposition, systems, drug product disposition, and Material Review Board.  This individual will provide oversight of projects with Disposition impact, APQR data compilation, Disposition metrics, CAPAs owned by Disposition, Deviations owned by Disposition, Change Control Impact Assessments, Change Controls owned by Disposition, product and will perform routine Material Review Board support.
Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Devens.  This role will interface with multiple departments including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, Digital Plant, and Site Manufacturing Sciences & Technology

Key Responsibilities
Support the overall Quality Disposition (QD) Organization by:
•    Owning and driving Quality System records
•    Performing product and change impact assessments
•    Support the systems and data requests needed
•    Maintain QD monitoring tools and metrics
•    May represent the QD program in audits and inspections
•    Performing routine Drug Product and Incoming Material disposition, as required, during peak and overflow periods
•    Maintain inspection plans and SAP infrastructure for disposition operations
•    Perform testing for eSystem changes as needed
•    Other tasks as required by Quality Disposition leadership

Support the Material Review Board (MRRB) program by:
•    Monitoring quality events and impact assessments, as needed, for potentially non conforming lots  
•    Sending Pre-MRB Notification to Mgt and MRB stakeholders along with scheduling MRB meetings and deliverables
•    Collaborating with SMEs to obtain inputs and investigative information for MRB decision-making
•    Attending MRB meetings and assisting in determination, with MRB, available treatment options for patients
•    Managing confidential MRB documentation appropriately
 

Qualifications & Experience
•    Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
•    6+ years of experience in a regulated industry with 1+ year quality system experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. 
•    Demonstrated experience with electronic system and databases
•    Ability to research, understand, intepret 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
•    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 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 changing priorities