Bristol Myers Squibb

Director

• Define, own, and drive BMS's Global Sterility & Microbiology Assurance Strategy
• Govern BMS's enterprise-wide Contamination Control Strategy as a living, risk-based framework
• Serve as the primary executive-level contact for contamination control and sterility assurance
• Embed contamination control, aseptic assurance strategy, and aseptic-by-design principles into processes and product development programs
• Lead remediation plans following regulatory observations
• Drive continuous improvement, KPI trending, capability development, and process confirmations
• Establish and govern global sterility/aseptic assurance and CCS performance metrics, escalation thresholds, trend analysis, and executive reporting
• Support implementation of BMS's Sterility Assurance Strategy across CMO partners
• Lead CMO CCS and Aseptic/Sterility Assurance Roadmaps, KPI analysis, gap assessments, due diligence, and alignment of standard operating procedures
• Provide technical oversight of microbiological controls across pharmaceutical, biopharmaceutical, cell therapy, radiopharmaceutical, and drug product operations
• Lead identification, qualification, and validation of terminal sterilization suppliers
• Drive advanced analytics, digital environmental monitoring, and data-driven contamination surveillance
• Lead or oversee cross-site microbiological investigations, CAPA development, root cause analysis, and remediation
• Maintain expertise in global sterility assurance regulations and industry standards
• Support regulatory filing reviews and lead or support global regulatory inspections
• Lead assessment and adoption of updated regulations such as Annex 1
• Ensure CMOs and internal sites maintain inspection readiness
• Apply business planning, capital planning, and business case development to aseptic/sterility assurance investment decisions
• Influence external trade associations, scientific and regulatory forums, and standard-setting bodies
• Lead and develop a globally distributed sterility assurance and microbiology team
• Build the central MQSA function, defining structure, roles, operating model, and ways of working
• Develop broader organizational capability through training, coaching, and mentoring
• Develop talent pipelines, career growth, and succession planning within Quality
• Foster contamination prevention, quality ownership, and continuous learning across the organization

Executive Director, Microbiology Quality, Sterility Assurance

• Design, manage, and improve cross-pillar capabilities for BMS Global Supply Chain
• Advance and improve a horizontal business capability across Global Supply Chain
• Collaborate with GSC pillar leadership, functional teams, IT, finance, and other capability owners
• Deliver capabilities across people, process, technology, and data
• Ensure cross-functional alignment across Commercial, Finance, Manufacturing, and Supply Chain for an integrated S&OP plan
• Lead end-to-end process standardization and transformation across pillars
• Define process improvement and capability evolution roadmaps
• Use benchmarking and process KPIs to identify capability improvement opportunities
• Lead large and complex capability programs and matrix-lead sub-programs
• Develop training content, KPIs, and change management to drive user adoption
• Provide dotted-line leadership, coaching, and guidance to capability leads
• Manage internal and external stakeholder relationships
• Provide process expertise and maintain accurate business process models
• Enable accelerated organizational change through digital evolution
• Ensure regulatory compliance, governance, and data integrity
• Drive the department’s overarching digital strategy as Business Systems Owner
• Identify and champion emerging technologies such as AI and automation
• Lead digital process redesign and capability-building projects using SAP IBP, Kinaxis, AERA, and cloud-based analytics
• Foster a digitally capable team culture through continuous learning and experimentation
• Apply AI/ML features for performance management and optimization
• Report to the Senior Director, Global Demand and S&OP Lead, Business Performance & Transformation, Global Supply Chain

Executive Director, Microbiology Quality, Sterility Assurance

Director, Global S&OP Capability Owner