Manager, Shop Floor QA (Day Shift)

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 Manager, Shop Floor QA is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations.

This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. This position is a people manager position, leading a team of individual contributors in the Quality Assurance Shop Floor Organization.

Shifts Available:

B1, 6am – 6pm, rotating schedule including holidays and weekends, onsite

Responsibilities:

• Oversee performance of QA shop floor activities.
• Supervise Quality Assurance Shop Floor employees.
• Regularly spend time coaching and mentoring operators and QA personnel while on the manufacturing floor. Provide guidance and training on quality programs.
• Lead Quality on-the-floor oversight to Manufacturing/QC/Warehouse/ Packout operations. Proactively identify risks/critical issues and drive mitigations and escalate to management as needed.
• Develop, review and/or approve temporary and non-routine procedure for event response.
• Periodically observe operations. Proactively identify risks and drive improvements.
• Provide quality oversight to non-routine maintenance work. Review and approve return to service plans.
• Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform review of operational documentation including manufacturing batch records.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

Knowledge and Skills:

• Previous Supervisory / Managerial Experience is preferred.
• Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks manageme