Senior Specialist, QA Deviation Reviewer and Approver

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, QA Operations Deviation role will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility, in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of procedures and methods; providing compliance oversight; ensure accurate and timely review of manufacturing and laboratory investigations; and identifying any trends.

Shift Available:

• Sunday - Wednesday, Onsite Day Shift, 8 a.m. - 6 p.m.

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

• Wednesday - Saturday, Onsite Day Shift, 8 a.m. - 6 p.m.

• Wednesday - Saturday, Onsite Afternoon Shift, 1 p.m. - 11 p.m.

• Monday - Friday, Onsite Day Shift, 9 a.m. - 5 p.m.

Responsibilities:

• Supports all activities for the Quality Operations Investigations group.

• Review and approve Site operational investigation.

• Review and approve Supplemental actions.

• Review and approve Impact assessments or Product Quality Evaluation Approval.

• Review and Approve Corrective and Preventive Actions (CAPA Plan, Action approval, Effectiveness Check (EC) Plan, EC execution Approval).

• Participate in Audit and inspection including inspection readiness activities.

• Attend and participate at Investigation and CAPA Review Board (IRB/CRB).

• Review and approve Investigation Protocol/Plan and Summary report.

• Review and approve interim controls (Mitigation protocols) for continued production.

• Review and approve Proactive Initiatives.

• Review and approve Standalone actions.

• Contribute to deviation management procedure improvement.

• Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.

Knowledge & Skills:

• Must be skilled in planning and organizing, decision-making, and building relationships.

• Able to effectively work in a dynamic / fast-paced environment.

• Meets and exceeds all safety expectations and adheres to all BMS behaviors and values.

• Must have knowledge on the review of deviation investigation and CAPA.

• Must have knowledge on how to perform Root Cause Investigation.

• Must have knowledge and experience with cGMP manufacturing, Quality, and Compliance.

• Must partner with Investigation team for efficiently and timely completion of deviations.

• Proactively seeks to resolve deviations/investigation roadblocks impeding deviation and/or CAPA record on-time closure and release to patients.  

• Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality