Sr Specialist, QA Investigations

About the role

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. The Senior Specialist, QA Investigations, is responsible for quality oversight and approval of Deviation investigations and associated Action and Effectiveness Check records at the Summit Cell Therapy Facility. The role provides Quality oversight and assurance of the quality of manufactured products, in compliance with all applicable regulations and BMS policies and guidelines. How you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities.

Responsibilities

• Review and approve investigations/ CAPAs / effectiveness checks associated with the manufacturing site including but not limited to materials, manufacturing, laboratory, facility, and computer systems.
• 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 and Effectiveness Check plans are robust and adequately addresses the root cause.
• May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.
• Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects.
• Support internal and external inspections as required.
• Maintain compliance with assigned learning plan.
• Support development and delivery of training content to cross functional teams.
• Lead meetings and represent function at cross functional meetings.
• Share data/ knowledge within