Sr. Manager, Contamination Events and Investigations

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.

Investigation Impact Assessment – Internal Sites Support complex microbiological and sterility assurance investigations at BMS internal manufacturing sites, including environmental monitoring (EM) excursions, sterility test failures, and process-related contamination events Serve as the MQSA SME providing microbiological and aseptic process impact assessments for investigations. Apply advanced microbiology, contamination control, and aseptic processing knowledge to critically evaluate root cause analyses (RCA) and assess product, process, and patient impact. Review and provide formal sign-off on impact assessment sections of investigation reports, CAPA records, and deviation documentation, ensuring conclusions are scientifically sound and aligned with regulatory expectations (FDA, EMA, ICH). Partner with site Investigation Leads to ensure investigation scope, RCA depth, and CAPA effectiveness adequately address microbiological and aseptic process risk. Rapid Response & Triage: Lead immediate containment and triage efforts for sterility breaches, including leaks, mold recoveries, and contamination events across a broad network of stakeholders. Track and trend impact assessment outcomes across sites to identify systemic issues and emerging risk patterns requiring escalation. Support preparation for regulatory agency inspections and audits related to impact assessment findings and sterility assurance. External Manufacturing (ExM) Support Serve as MQSA technical liaison for ExM partners on sterility and microbiological investigations, providing SME guidance to ensure investigation quality aligns with BMS standards. Partner with site the MS&T Virtual plant teams (VPTs) lead to ensure investigation scope, RCA depth, and CAPA effectiveness adequately address microbiological and aseptic process risk. Critically review impact assessments and investigation reports submitted by ExM partners, providing constructive feedback to drive adequate risk evaluation and CAPA responses. Support quality risk assessments at CMOs, including periodic risk reviews of aseptic processing operations, contamination control programs, and microbiological data trends. Design and implement standardized CMO oversight tools, dashboards, and decision trees for aseptic and microbial control performance Participate in remote and on-site technical reviews with contract manufacturing organizations (CMOs) as needed during escalated events or regulatory commitments. Participation in site assessments/vendor selection for CMOs/vendor with Procurement, MS&T, Quality, and other business functions.  Technical SME on Quality Audit team for External manufacturing sites. Aseptic Process Support Provide technical expertise in aseptic processing principles, including barrier technology (RABS/isolators), cleanroom design, gowning programs, and aseptic technique qualification. Support aseptic process simulations (media fills) – planning, review, and failure investigation – and provide technical input on process validation and revalidation activities. Contribute to contamination control strategies (CCS) development and maintenance per Annex 1 (2022) requirements across internal and ExM sites. Assess and advise on aseptic process change controls, providing risk-based SME review of proposed changes to aseptic processing operations, equipment, and environments. Support implementation of current Good