Senior 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 Senior Manager, Quality Assurance Drug Product Disposition, Devens Cell Therapy role is responsible for the development, implementation, execution, and sustainability of quality and 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 of the Drug Product disposition program, ensuring timely and accurate delivery of disposition requirements from stakeholder groups such as Quality Control, Field Quality Assurance, and Manufacturing Operations. This individual will ensure accurate and timely release of drug product, maintenance, and review of SOPs, and acts 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 work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, Site Engineering, Digital Plant and Site Manufacturing Technology

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Must have advanced 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 and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Must possess an independent mindset and tenacity.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Work is self-directed.
• Confident in making decisions for minor issues.
• Routinely recognizes Quality issues and solves problems.
• 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.
• Contributes to goals within the work group.
• 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.
• Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
• Ability to make independent and objective decisions and to work with minimal supervision.
• Excellent verbal and written communication skills.

DUTIES AND RESPONSIBILITIES

• Responsible for oversight and implementation of the Drug Product disposition program
• Hire, train, and coach a mix of single contributor and first line people leaders to execute the book of work and sustain Drug Product disposition programs.
• Represent the Devens facility in network initiatives for harmonization and at community of practices
• Present and review the Drug Product disposition program with internal, global, and health authority auditors.
• Approve Cohort to Material and other SAP master data elements to support Drug Product disposition.
• Maintain quality Inspection Plans in SAP to align with procedural requirements for disposition activities.
• Approve Quality Control specifications.
• Oversee and approve all procedural documentation for the drug product disposition program

EDUCATION AND EXPERIENCE

• 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 and experience would be considered.

WORKING CONDITIONS:

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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

COVID-19 Information
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.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation 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 will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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