Senior Manager, Quality Assurance Material Operations, Cell Therapy

Senior Manager, Quality Assurance Material Operations, Cell Therapy

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.

The Senior Manager, Quality Assurance Material Operations, Cell Therapy role is responsible for the development, implementation, execution, and sustainability of quality and material disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. This individual will lead a team responsible for oversight and performance of the incoming material visual inspection, disposition, and eSystem master data programs.

The individual will ensure timely and accurate delivery of disposition requirements from stakeholder groups such as Quality Control and supply chain. This individual will ensure compliant release of incoming raw materials and consumables, maintenance, and review of SOPs, and act as a Subject Matter Expert in projects and regulatory inspections. Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Devens.

This role will work with Supply Chain, Manufacturing, Quality Control, Digital Plant, Supplier Quality, and other local and global stakeholder groups.

• Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
• Must be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Completes routine tasks with little or no supervision and moderate complexity tasks with input as needed from quality leadership.
• Confident in making decisions and problem solving for minor to moderate issues.
• Routinely recognizes Quality issues and opportunities for efficiency.
• Is recognized Subject Matter Expert within the group.
• Provides guidance to other employees in interpretation of complex data.
• Capable of providing input within the department and cross functional teams.
• Builds relationships internally within and with cross functional teams.
• Able to prepare written and verbal communications and convey problems to management with clarity and accuracy.
• Able to effectively multi-task.

• Responsible for oversight and implementation of the incoming material visual inspection and disposition programs
• Responsible for the oversight and implementation of highly complex and integrated eSystem quality master data approvals in ERP and electronic Batch Record systems (SAP and Syncade MES respectively).
• Hire, train, and coach a mix of single contributor and first line people leaders to execute the book of work and sustain programs.
• Represent the Devens facility in network initiatives for harmonization and at community of practices.
• Responsible for material control philosophy and oversight for the site
• Present and review the programs with internal, global, and health authority auditors.
• Approve Cohort to Material and other SAP/MES master data elements to support quality assurance
• Maintain quality Inspection Plans in SAP to align with procedural requirements for disposition activities.
• Oversee and approve all procedural documentation for incoming material programs.
• Approve new material requests for the site
• Interface with global Material Planning, Supply Chain, and Supplier Quality teams as Devens site representative.
• Perform impact assessments and own Quality System records for the incoming and master data programs.
• A minimum of 8 years of experience in the pharmaceutical or related GMP industry.
• A Bachelor's degree in a biological science, engineering, or similar. An equivalent combination of education, military service, and experience will be considered.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Devens - MA - US: $130,020 - $157,559

The…