Manager, Quality Assurance Drug Product Disposition 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 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 Quality Assurance Product Disposition Manager is responsible for supervising quality and disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. The role will oversee the routine and timely release of drug product and assure the quality of manufactured products is in compliance with all applicable regulations and guidelines. Functional responsibilities include performing product release within the inventory management system (SAP), ensuring accurate and timely maintenance and review of batch record documentation, providing operations shop floor oversight, and performing document issuance for manufacturing. This individual will also be responsible for maintenance and review of SOPs, and act as a Subject Matter Expert in product disposition.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Must have knowledge and experience with cGMP manufacturing, Quality, and compliance as well as US and global cGMP requirements.
• Demonstrates a high degree of attention to detail, with strong documentation expertise. Able to effectively multi-task and demonstrate strong organizational skills.
• Excellent verbal and written communication skills with ability to prepare written communications and communicate problems to management with clarity and accuracy.
• Demonstrated ability to develop and maintain strong business partner relationships internally and with cross-functional teams. Able to effectively work across functional groups and teams to ensure requirements are met.
• Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Requires direction to complete more complex tasks; completes routine tasks with little supervision. Confident in making decisions for minor issues and routinely recognizes Quality issues and solves problems.
• Is recognized Subject Matter Expert within the group for disposition process and provides guidance to other employees in interpretation of complex data.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Knowledge of electronic systems including any of the following: SAP, Veeva, LIMS/Celabs, Infinity, and electronic batch recording.
• Knowledge of quality processes, tools, and methodologies.
• Acts as an advisor to constituent units and becomes actively involved as required to meet schedules or resolve problems. Exercises judgment within defined procedures and policies to determine appropriate action.

DUTIES AND RESPONSIBILITIES

• Participates in the startup of the Devens Cell Therapy facility, including the development of Standard Operating Procedures, training, and business processes supporting drug product disposition.
• Supervises and performs the execution of routine product disposition activities by ensuring all relevant documentation associated is accounted for, completed, and approved under GMP standards.
• Verify accuracy and acceptability of drug product documentation, such as Certificate of Analysis or deviation reports, to support drug product batch disposition.
• Provides coaching, training, and professional development to their team members to develop their skills and create an environment of continuous learning, improvement, and innovation.
• Contributes to and supports the site team which prepares for, hosts, and responds to Health Authority inspection reviews and approvals of the facility and products
• Perform required updates to lot status in applicable quality systems. Ensure batch disposition status is monitored and communicated to appropriate stakeholders.
• Perform the review of batch genealogy for all raw materials and components used in each lot to ensure that they are approved and released.
• Develops process improvement strategies and supports execution of site/team continuous improvement goals and projects.
• Participates and supports internal and external audit activities as needed,
• Provides guidance to less experienced staff with atypical events during day-to-day operations.

EDUCATION AND EXPERIENCE

• B.S. in a life or physical science related discipline.
• Minimum of 6 years of pharmaceutical experience or related GMP industry.
• Previous people or team leadership experience is desired.

BMSCART

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Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

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