Manager, QA Investigations and CAPA

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.

As the Manager, QA Investigations and CAPA, you will be responsible for the deviation investigation approvals, and CAPA approvals and ensure adherence to applicable GMP regulations and BMS policies and procedures.  Incumbent will also provide consistent direction and ensure timely completion of their deviation investigations and CAPAs to ensure success during regulatory inspections.

Shift Available:

• Sunday - Wednesday or Wednesday - Saturday, 4 p.m. - 2 a.m. Onsite

Responsibilities:

• Review and approve complex investigations/ CAPAs / effectiveness checks associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems.

• Author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program.

• Ensure the corrective/ preventive actions are robust and adequately address the root cause.

• May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.

• Participate in monthly COP forum.

• Lead or participate on globally driven sub teams to drive investigation excellence and improvements.

• Drive deployment of effective deviation processes within representative site/function.

• Coach employees on aspects of investigations.

• Resolve investigational process or system issues.

• Ensure appropriate issues are cascaded to global team and liaise with global team on routine basis.

• Champion for culture of quality within the deviation program.

• Proactively monitor metrics and take relevant actions (including work prioritization) to ensure that disposition timelines and other targets are met.

• Identifies improvement opportunities and drives execution of site/team continuous improvement goals and projects.

• Support internal and external inspections as required.

• May present individual topics during audits as needed.

• Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams.

• Support integration of newer team members

• Acts as Subject Matter Expert of the deviations program and provides guidance/ coaching to less experienced staff with atypical events during day-to-day operations.

• Lead meetings and represent function at cross functional and network meetings.

• Share data/ knowledge within and across site and network. Build & maintain strong relationships with partner functions.

Knowledge & Skills:

• Demonstrated experience with electronic system and databases.

• Demonstrated proficiency in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.

• Deviations Program Subject Matter Expert.

• Ability to work in a fast-paced team environment and lead peers through changing priorities.

• Ability to think strategically, meet deadlines and supp