Manager, Quality Assurance Drug Product Disposition, Cell Therapy F

Bristol-Myers Squibb

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 .

Position Summary

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. This individual will support the Sunday – Wednesday shift when it is implemented at the site.

Functional responsibilities include leading and managing a team, performing product release within the inventory management system (SAP), and ensuring accurate and timely review of drug product documentation. This individual will also be responsible for maintenance and review of SOPs, and act as a Subject Matter Expert in product disposition.

Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Devens. This role will interface with multiple departments including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, Digital Plant, and Site Manufacturing Sciences & Technology

Key Responsibilities

• Develops and maintains 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 lot 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.
• May need to hire, coach, and develop a team to support the drug product disposition process.
• 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.

Qualifications & Experience

• Minimum of 6 years of pharmaceutical experience or related GMP industry. Previous quality experience is preferred.
• A Bachelor’s degree in a biological science, engineering, supply chain, or similar or an equivalent combination of education, military service, and experience.
• Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
• 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 moderate direction to complete more complex tasks; completes routine tasks with little supervision.
• Confident in making decisions for minor issues.
• Routinely recognizes Quality issues and solves problems.
• Is recognized Subject Matter Expert within the group.
• Capable of providing input within the department and cross functional teams.
• Builds relationships internally within and with cross functional teams.
• Able to recognize conflict and notify management with proposed 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.
• Excellent verbal and written communication skills.

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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.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients’ lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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