Senior Manager, Quality Engineering 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, Quality Engineer is responsible for quality oversight of engineering and validation lifecycle activities, including facility, equipment, and utility commissioning and qualification, computer systems validation, process validation, and technology transfer. The Senior Manager, Quality Engineering is responsible for quality oversight.

Shifts Available:

TBD

Responsibilities:

• Act as project lead for QA validation / engineering oversight.
• Managing deliverable timelines, and business process improvements.
• QE lead of the review, approval, and quality decision making for commissioning and qualification lifecycle documentation associated with large and/or complex facility, equipment, or utility projects, including but not limited to system/component impact assessments, user requirements, configuration specifications, installation/operational qualification, performance qualification, etc.
• QE lead of the review, approval, and quality decision making for computer systems validation lifecycle documentation associated with manufacturing site digital systems, including but not limited to system classification, user requirements, functional specifications, installation qualification, operational qualification / system testing, user acceptance testing, performance qualification, periodic review, etc.
• QE lead of the review, approval, and quality decision making for process validation lifecycle documentation associated with manufacturing site processes, including but not limited to engineering run, process validation, mixing studies, aseptic process simulation, process performance qualification, process data reviews, continued process verification, etc.
• Act as SME and/or Quality reviewer/approver for complex risk assessments, data integrity assessments, and technical reports supporting the manufacturing process and supporting systems.
• May perform routine quality review/approval activities associated with equipment/system onboarding and status
• Represent Quality on large capital projects or technology transfer initiatives and review/approve complex validation or master transfer plans.
• Identifies improvement opportunities and drives execution of site/cross-functional continuous improvement goals and projects, including sharing best practices, and harmonization
• May review and approve or provide impact assessment for complex site and global change controls.
• Support internal and external inspections as required. Participate in the preparation and execution corrective and preventative actions related to inspection findings.
• Maintain compliance with assigned learning plan. Support development of training content.
• Act as validation Subject Matter Expert in multiple validation disciplines and provide guidance/ coaching to less experienced staff and cross-functional partners with atypical events during qualification.
• Lead meetings and represent function at cross functional and network meetings.
• Share data/ knowledge within and across site and network.
• Build & maintain strong relationships with partner functions and global counterparts. Influence network teams on site behalf.

Knowledge and Ski