Manager, Quality Assurance Shop Floor, Cell Therapy - Devens, MA

Location: Devens

Job Description

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Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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 Quality Assurance Shop Floor (QASF) organization has responsibility for quality oversight and responsibility for advising and assuring quality operations at the Devens Cell Therapy Facility in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global current Good Manufacturing Practices (cGMPs).

In the capacity of QA Shop Floor Support, the Manager, Shop Floor QA, Cell Therapy shall be responsible for handling Quality Assurance Shop Floor internal compliance and documentation tasks, routine communication to front line employees, and metrics/monitoring for key QASF processes. The incumbent will be considered a local process owner for core QASF systems/processes including but not limited to Alarm Review, Batch Record Review, and the GMP Walkthrough Program.

The incumbent will be the steward for standard operating procedures, training, and managing relationships with key stakeholders.

They will be accountable to monitor and track process performance related to key Shop Floor quality assurance quality tasks and other operational tasks through data and analytics; to own, review or approve Floor Quality GxP records including but not limited to procedures, CAPAs, change controls, impact assessments, documentation, or deviations; and represent QASF at relevant governance forums. Additionally, the incumbent shall flex to support ad-hoc deviation approval or batch record review as requested by management.

Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed.

This position reports to the Associate Director, Shop Floor Quality Assurance.

This is an individual contributor role working Monday to Friday.

Shifts Available:

M - F, Standard Working Hours

Responsibilities:

Accountable for the performance/delivery of the QASF quality organization, including oversight of the "QA on-the-floor" systems and programs that enable the highest quality and the quickest delivery of QA cGMP tasks.
Develop and implement, and continuously improve standard procedures and training for team-members related to quality systems.
Proactively identify and address quality risks and critical issues, drive mitigations with the aid of Quality Assurance staff and cross-functional partners…