Executive Director, Microbiology Quality Sterility Assurance

Career Areas Career Stories Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Careers Home Life at BMS Career Areas Student Opportunities Events How We Recruit Career Stories Search this site Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Single PositionView All JobsExecutive Director, Microbiology Quality Sterility AssurancePrinceton - NJ - US +4 moreNo longer accepting applications.Job IDR1602985Date posted05/30/2026DepartmentNot ApplicablePosition SummaryThe Executive Director, Microbiology Quality Sterility Assurance (MQSA) is a pivotal global leadership role within BMS's Corporate Quality organization. This position brings critical expertise in sterility assurance, microbiological controls, and contamination control strategy across BMS's internal and external commercial and PD manufacturing sites — spanning pharmaceutical, biopharmaceutical, cell therapy and radiopharmaceuticals. This role is responsible for defining, owning, and governing BMS's enterprise-wide Contamination Control Strategy (CCS) as a living, risk-based framework — ensuring alignment with EU GMP Annex 1, FDA, and all applicable global regulatory standards.The Executive Director serves as the global Single Point of Contact (SPOC) for all sterility assurance and microbiology quality matters, partnering with Product Development (PD), Materials Science & Technology (MSAT), Quality, Internal Manufacturing, and External Manufacturing (EXM) to ensure the highest standards of microbiological control are embedded across BMS's manufacturing network.This is a highly strategic and visible role, operating at the intersection of technical excellence, regulatory compliance, contamination control governance, business planning, and people leadership — with significant influence at the senior executive level.The Executive Director is expected to build and lead this newly established central function, establishing it as a center of excellence for CCS and sterility assurance across BMS's global network.Key ResponsibilitiesStrategic Leadership & Sterility Assurance Governance•  Define, own, and drive BMS's Global Sterility & Microbiology Assurance Strategy, ensuring alignment across all manufacturing sites, CMOs, MS&T, GTS and PD partners•  Serve as the primary executive-level contact for contamination control and sterility assurance across Operations, Engineering, MS&T, and PD•  Embed control contamination and aseptic assurance strategy and aseptic-by-design principles into future processes and product development programsLead remediation plans following regulatory observations, ensuring proactive installation of appropriate aseptic assurance standards (QMS and standard work) across the businessChampion continuous improvement initiatives including KPI trending and capability development in aseptic and sterility assurance domains and process confirmationsOwn and periodically review BMS's Global CCS as a living document, ensuring it reflects current regulatory requirementsEstablish, own, and govern BMS's global sterility/aseptic assurance and CCS performance metrics framework, including KPI definitions, network-level escalation thresholds, trend analysis, and executive-level reporting cadenceCMO & External Partner ManagementSupport any implementation of BMS's Sterility Assurance StrategyLead CMO support in establishing and executing annual Contamination Control Strategies (CCS) and Aseptic/Sterility Assurance RoadmapsPartner with CMOs for KPI...