Specialist/Sr. Specialist Data Integrity

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 Specialist or Senior Specialist, Data Integrity role is responsible for assisting with the implementation and management of Bristol Myers Squibb’s GMP Data Governance and Data Integrity program at the Summit West, NJ CAR T manufacturing facility. This includes implementing documentation and processes in support of the laboratories, manufacturing, and GMP support areas.

Shift Available:

• Mon-Friday, Hybrid Day Shift, 8 a.m. - 5 p.m.

Responsibilities:

• Responsible for executing data integrity documentation periodic reviews and performing risk monitoring of implemented systems across all sites to ensure continued compliance.

• Responsible for assisting with the implementation of Global Data Integrity Processes at the site and ensuring that Global programs are implemented on-time.

• Assist in ensuring local site activities are harmonized with Global DG/DI standards.

• Provide feedback and support to GMP areas in scope during process improvement, while ensuring compliance with Global DG/DI policies and standards.

• Responsible for ensuring systems at Summit West, NJ CAR T facilities comply with data life cycle requirements from initial data creation/recording to archival and decommissioning. This includes, but is not limited to, data management (e.g., data creation, data processing, review, reporting), data security, data traceability, process mapping, data backup/restore, electronic signature/electronic record linking and data audit trails.

• Responsible for creating and executing data integrity assessments of new and existing systems including, but not limited to, manufacturing and laboratory systems to ensure compliance with regulatory requirements and company established requirements for data integrity.

• Drive mitigation and remediation when data integrity gaps are identified.

• Work with functional area SMEs at Summit West CAR T facility to ensure data risks are identified, remediated and prevented.

• Seek out and recommend to management opportunities for increased data integrity program efficiencies and operational improvement through modifications to current systems, implementation of new systems and more efficient use of established systems.

• Provide the GMP functions any updates regarding data integrity regulations that they may be impacted by.

Knowledge & Skills:

• Must have familiarity with GMPs, Quality, and Data Integrity principles.

• Must be familiar with system validation principles.

• Must be familiar with the ALCOA+ principles and their application to both electronic and paper data.

• Must be able to effectively interpret proble