Head of QA Technical Operations

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 Sr. Director, Quality Technical Operations, Cell Therapy Manufacturing is responsible for leading the day-to-day quality review and approval of investigations, CAPA, Change Controls with associated documents and the oversight of the Quality Engineering team responsible for qualifications and validations of computerized systems, software, enterprise systems, equipment, methods, and manufacturing processes. The Sr. Director, Quality Technical Operations will serve as a primary delegate and proxy for the Head of Quality, Cell Therapy Manufacturing at Summit, and is as a champion for quality principles and compliance within the organization. 

Shift Available:

• Monday - Friday, Hybrid Day Shift

Responsibilities:

• Responsible for QA oversight of cGMP operations deviations, CAPAs, Change Controls, and qualification/validation at the Summit, NJ Cell Therapy manufacturing facility (S12).  Drives for operational adherence to applicable cGMP regulations, BMS policies and procedures.

• Provides direction to Operations, Facilities, QC, and QA teams for planned and unplanned deviations to resolve compliance issues and procedural errors, ensuring immediate containment actions are taken, assisting investigators on deviation strategy and documentation, reviewing and approving deviations, supporting identification of appropriate CAPA, and supporting site awareness / retraining following any events.

• Strategically identifies, implements, and leads site-wide QA transformational programs and strategies in close partnership with Quality Systems, MS&T, Operations, Supply Chain and Quality Control to reduce Deviations, improve right first time, improve Quality record timeliness, identify and remediate trends, improve turnaround time (TAT), and prevent issues before they occur.

• Ensures timely Quality support and approval of GMP documentation, risk assessments and change control impact assessments.

• Ensures the required processes, procedures, systems, and resources are in place to enable a compliant manufacturing of CAR T products.

• Maintains a comprehensive understanding of S12 manufacturing, QC testing processes and the associated risk management control strategy to identify process risks and associated critical controls around the associated processing steps.

• Effectively partners with Manufacturing leadership to enhance technical knowledge of operators and shop floor through timely, positive, and constructive feedback and training.

• Serves as primary Delegate of Authority (DOA) and proxy for the Head of Quality, Cell Therapy Manufacturing, Summit, NJ.

• Acts as subject matter expert for GMP operations during audits and regulatory inspections.  Contributes to the development and execution of the S12 inspection readiness plan.  Supports and facilitates Health Authority interactions, and ensures any regulatory observations are adequately addressed and completed on time. 

• Works together with the S12 Quality Leadership Team to deploy a strategy that fosters a rich team culture, enhances employee satisfaction and retention, and drives a high-performing team.

• Provides leadership and builds an exceptional team to manage QA functions, including hiring, mentoring, and developing personnel.

• Provides expertise and guidan