Manager, CAR T Manufacturing Records and Procedures

Manager, CAR T Manufacturing Records and Procedures

Join to apply for the Manager, CAR T Manufacturing Records and Procedures role at Bristol Myers Squibb
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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. 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:

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.

• Attend alignment meetings.
• Create and review QMS deviations, provide feedback, and ensure timelines are met.
• Complete investigations for deviations.
• Review drafts completed by technical writers and provide feedback, coaching, and mentoring.
• Facilitate process and site knowledge to MO organization and coordinate ongoing change efforts.
• Track and trend deviations (closure time and pattern/recurring events).

• Schedule and monitor CAPAs to ensure on‑time closure/implementation.
• Collaborate with cross‑functional departments to build and leverage ideas, data, and insights for CAPAs, effectiveness checks, and document updates.
• Open CAPAs as needed.
• Complete CAPA actions within QMS.
• Challenge and/or justify CAPA actions.
• Identify compliance gaps and work cross‑functionally with stakeholders to make necessary updates to documents.
• Ensure on‑time closure of CAPAs and effectiveness checks for the MO organization.

• Ensure on‑time closure of change controls actions for the MO organization.
• Collaborate with cross‑functional departments to build and leverage ideas, data, and insights for parent change controls, change control actions, impact assessments, and effectiveness checks.
• Open parent change controls and change control actions as needed to revise documents to support new product/process implementation.
• Work cross‑functionally to update procedures to address procedural gaps and/or new processes implementation.
• Attend alignment meetings.
• Challenge and/or justify change controls.
• Facilitate pre‑CCRB meetings and attend CCRB.

• Lead and participate in continuous improvement initiatives.
• Help lead reduction of human error deviations by data tracking and continuous improvement.
• Actively participate and lead the team in improving processes.
• Develop and optimize work processes, simplifying and standardizing.

• Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products.
• Knowledge of cGMP and FDA regulated industry.
• GMP, Quality, and in‑depth risk management knowledge.
• Basic mathematical skills.
• Strong technical and compliance writing capability.
• Proficient in MS Office applications.
• Background in biology, chemistry, medical or clinical practices.
• Previous experience leading and closing deviation investigations.
• Experience in the CAPA process and ability to identify and verify effectiveness.
• Advanced experience with deviation investigations, utilizing root cause analysis tools.
• Ability to accurately understand, interpret, and apply Global Regulatory and cGMP requirements.
• Experience supporting health authority inspections.
• Knowledge of data trending and tracking,…