Senior Specialist, QC Compliance, 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.

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 Specialist, QC Compliance is a full-time position supporting to lead and author QC deviation, laboratory investigations, CAPAs and change control. within the S12 CAR T Quality Control department. The primary focus of this role is to support QC deviations, laboratory investigations, CAPAs and change controls in collaboration with the QC functional areas.

Shift Available:

• Sunday - Wednesday, Hybrid Afternoon Shift 1 p.m. - 11 p.m.

Responsibilities:

• Work with QC SMEs to conduct root cause analysis. Ensure timely and compliant closure of investigations, deviations, CAPAs and change controls.

• Perform document revision, project, CAPA and deviation/ investigation, change mgmt. actions, related tasks and/ or continuous improvement efforts.

• Train and mentor others on deviation, investigation, CAPA and change control process/ procedures.

• May support health agency inspection as equipment area subject matter expert.

• Communicate effectively with management and cross functional teams (e.g., present investigation findings at governance forums).

Knowledge & Skills:

• Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.

• High problem-solving ability/mentality, critical thinking, technically adept and logical.

• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.

• Ability to work in a fast-paced team environment, action oriented, highly organized to meet deadlines and prioritize work.

• Knowledge of cell therapy analytical and microbiological testing required.

• Demonstrated experience with Quality management systems.

• Demonstrated technical writing skills.

Basic Requirements:

• Bachelor’s degree in science, engineering, or related discipline. An equivalent combination of higher education and experience will be considered.

• 4+ years of experience in QC lab operations.

• 2+ years of prior investigation experience required.

Preferred Requirements:

• Previous CT experience.

BMSCART, #LI-Hybrid

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 condu