Manager, Shop Floor Quality Assurance, Cell Therapy

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"- a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.

This is work that transforms the lives of patients, and the careers of those who do it.

Shift: Day Shift, 6am - 6pm, rotating schedule including holidays and weekends, onsite

This is a key role on the Shop Floor Quality Assurance team. As Shift Manager for the A1 Shift (6am to 6pm), you will lead a team of 4-8 Specialists. The Shop Floor Quality Assurance team 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 teams to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.

The Manager, Shop Floor Quality Assurance, Cell Therapy is responsible for quality activities for the Cell Therapy Facility in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring operational compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.

The Manager, Shop Floor Quality Assurance role is stationed in Devens, MA and reports to the Senior Manager, Field Quality Assurance for the Devens CTF.

Provide leadership to ensure routine on-the-floor Quality oversight and to ensure collaborative triages of unexpected events within the Manufacturing, Quality Labs, and Supply Chain operational areas and systems. Have a comprehensive understanding of Cell Therapy processes to enable real-time decision-making. Advanced ability to synthesis information from multiple sources, interpret problems and effectively communicate to cross-functional management in a clear, brief, and accurate manner.

Respond to complex/critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to continue manufacturing. Serve as a subject matter expert supporting others to navigate the BMS quality management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and batch record management. Provide direction and timely guidance to QA shift-managers regarding the handling and resolution of cGMP events which may be a part of deviations, batch record exceptions, and other quality operational issues.

Accountable for the performance/delivery of the QA field 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 standard-work for team-members that balances on-floor support for non-routine events, routine quality assurance work, and stretch/development project-work. Champion a culture that embraces psychological and physical safety of employees in the work environment.

Champion a culture of teamwork, communication, and continuous improvement focused on defining problem statements, driving initial investigative efforts, and actioning solutions to reduce recurrence. Proactively identify and address quality risks and critical issues, drive mitigations with the aid of Field Quality Staff and cross-functional partners and escalated to senior management as needed. Lead walkthroughs with peers or QA team-members to identify and remediate operational or quality issues.

Review and interpret the technical conclusions of a record/investigation and provide constructive feedback. Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge Regularly spend time coaching and mentoring operators and Field QA specialists while on the manufacturing floor. Interview, hire, coach, motivate, and develop exceptional staff. Set performance objectives and development plans.

Monitor performance progress and conduct performance reviews…