Conducting and managing the resolution of complex/multi-functional root cause investigations, including impact assessments, CAPAs, and product complaints as a Lead Investigator Collaborating with many different groups/organizations as a Lead Investigator including Process Engineering and Support, Engineering and Facilities, Manufacturing Operations, Quality Assurance, and Quality Control Proactively managing the progression of investigations and CAPAs to timely and compliant closure per established KPIs Presentation of investigation findings to key stakeholders and site senior management Use of Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; Actively supporting regulatory inspections Staying current with industry trends and BMS standards and participating in best practice forums consistent with function responsibilities. Coaching and mentoring of colleagues on Investigation Program fundamentals and best practices. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities Experience utilizing root cause analysis tools and identifying corrective and preventative actions is required Experience with Operational Excellence and Lean Manufacturing is a plus Experience in cell therapy, biologics, or vaccine manufacturing/support desired Proficient in cGMP's and multi-national biopharmaceutical/cell therapy regulations Excellent verbal/written communication skills and ability to influence at all levels Ability to think strategically, and to translate strategy into action Ability to prioritize and provide clear direction to team members in a highly dynamic environment Experience in product complaints and/or APQRs is a plus Knowledge of science generally attained through studies resulting in a Bachelor's degree in science, engineering, biochemistry or related discipline plus a minimum of 5 years' experience in biopharmaceutical operations, or its equivalent is required