Senior Manager, QA Material Review Board

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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.

The Senior Manager is a people leader responsible for the performance of the QA team that coordinates and leads the Material Review Board (MRB) meetings for commercial and clinical products manufactured at the NJ CAR T Summit (S12) manufacturing site. The Senior Manager is accountable for the completion of MRB deliverables in accordance with site and global requirements as well as they are responsible for the development and growth of the Material Review Board lead and associates. The Senior manager participates in continuous MRB process initiatives and represents the Summit (S12) Material Review Board within in the CAR T global network.

Shift Available:

• Monday - Friday, Hybrid Day Shift

Responsibilities:

• Chairs Material Review Board (MRB) meetings. Reviews and approves MRB minutes and executive summaries and notifies senior leadership of any risks or delays to product release.

• Approves post MRB documentation in the Quality Management System.

• Oversees and approves procedures for the MRB program.

• Leads day to day activities, develops skills, and supports career growth of all direct reports.

• Updates and procures approval of job descriptions for department personnel. Ensures appropriate training for all direct reports.

• Hires, develops, counsels, manages, and motivates staff. Writes and administers performance reviews for department personnel.

• Performs notification to management when applicable.

• Leads and critically review investigations, interpret results, and generate technical conclusions consistent with quality risk management principles.

• Responsible for applicable trending of compliance metrics within the Material Review Board.

• Represents Summit CAR T Material Review Board for meetings/projects both locally and within in the BMS CAR T network. Works with global partners to determine best practices for Material Review Boards across the BMS network.

• Stays abreast of industry standards as applicable to cGMPs and global regulatory guidelines and requirements.

• Acts as a Compliance and Right First Time Champion, resolving quality issues when applicable. Proposes solutions for complex issues and leads their resolution.

• Proposes and leads continuous improvement initiatives to increase group and site efficiency.

• Promotes a team culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving.

• Completes requests from cross functional business partners on behalf of the MRB team.

• Supports site and functional teams during regulatory inspections or audits, which may include direct interaction with inspectors/auditors as well as writing and/or reviewing responses.

• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

• Serves as Material Review Board Subject Matter Expert for the team, site and network.

Knowledge & Skills:

• General understanding of cGMP, ISO, FDA, MHRA, PMDA, USP, ATMP, PDA and EP regulations and guidelines as related to the manufactured of cell therapy products.

• General knowledge of CAR T manufacturing process (including proce