Manager, Field Quality Assurance, Cell Therapy (Night 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 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.

PURPOSE AND SCOPE OF POSITION:

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

This position requires shift work. This is a night shift role, working 6pm-6am. The shift rotates on a bi-weekly Panama schedule.  

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities

• 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 management guidance on complex issues.

• Able to recognize conflict and notify management with proposed recommendations for resolution.

• Must possess an independent mindset. Work is self-directed.

• Requires little direction to complete more complex tasks; completes routine tasks with little or no supervision.

• Able to provide directions to others within the team.

• Confident in making decisions for non-routine issues.

• Develops and revises procedures.

• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.

• Able to prepare written communications and communicate problems to management with clarity and accuracy.

• Able to effectively multi-task.

• Knowledge of US and global cGMP requirements.

DUTIES AND RESPONSIBILITIES

• Oversee performance of QA shop floor activities.

• Supervise Field Quality Assurance employees.

• Ensure manufacturing compliance with applicable procedures and batch records.

• Perform real time review of manufacturing batch records.

• Review manufacturing shop floor documentation.

• 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.

EDUCATION AND EXPERIENCE

• Supervisory experience highly preferred.

• High School Degree required.

• Relevant college or university degree preferred.

• Minimum 6+ years relevant work experience, with at least 3 years in a Quality Assurance role.

• Equivalent combination of edu