Bristol Myers Squibb
Pharmaceutical
ExecutiveDirector,MicrobiologyQualitySterilityAssurance
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“Executive Director, Microbiology Quality Sterility Assurance at Bristol Myers Squibb. Skills: Sterility Assurance, Microbiology Quality, Contamination Control Strategy, Regulatory Compliance. Define Global Sterility & Microbiology Assurance Strategy. Align strategy across manufacturing sites, CMOs, MS&T, GTS,”
Industry & Context.
Root cause analysis; Risk assessment; CAPA development
What They're Looking For.
Must Have
5+ years experience, Global Sterility & Microbiology Assurance Strategy, Contamination control and aseptic assurance strategy, Aseptic assurance standards, Global CCS, Sterility/aseptic assurance and CCS performance metrics framework, BMS's Sterility Assurance Strategy, Contamination Control Strategies (CCS), Aseptic/Sterility Assurance Roadmaps, KPI analysis, trending, escalation, and gap assessments, BMS standards (GQPs, QMS, FDA Guidance, etc.), Due diligence activities, Ways of working and standard operating procedures, Microbiological controls, Identification, qualification, and validation of terminal sterilization suppliers, Product design, process controls, and organizational capabilities, Advanced analytics, digital environmental monitoring tools, Data-driven risk assessment approaches, Contamination surveillance and trending, Cross-site microbiological investigations, CAPA development, Systemic remediation efforts, Robust root cause analysis, Sustainable corrective actions, Global regulations, guidance documents, and industry best practices, Sterility assurance, Microbiology, EU GMP, FDA, WHO, PDA, ASTM, ISPE, PhRMA, BMS internal standards, Regulatory filings, Sterility assurance-related regulatory inspections, FDA, EMA, MHRA, Health Authorities, New or updated regulations, Annex 1, CMOs and internal sites, Inspection readiness
What You'll Do.
Define Global Sterility & Microbiology Assurance Strategy
Align strategy across manufacturing sites
Serve as primary executive contact for contamination control
Embed control contamination and aseptic assurance strategy
Embed aseptic-by-design principles
Lead remediation plans
Install appropriate aseptic assurance standards
Champion continuous improvement initiatives
Develop capabilities in aseptic and sterility assurance
Conduct process confirmations
Establish CCS performance metrics framework
Define KPI definitions
Set network-level escalation thresholds
Support implementation of Sterility Assurance Strategy
Lead CMO support for CCS
Lead CMO support for Aseptic/Sterility Assurance Roadmaps
Partner with CMOs for KPI analysis
Partner with CMOs for gap assessments
Conduct due diligence for new CMOs
Drive alignment in ways of working
Drive alignment in standard operating procedures
Provide technical oversight of microbiological controls
Oversee pharmaceutical manufacturing operations
Oversee biopharmaceutical manufacturing operations
Oversee cell therapy manufacturing operations
Oversee radiopharmaceutical manufacturing operations
Oversee drug product manufacturing operations
Lead identification of terminal sterilization suppliers
Lead qualification of terminal sterilization suppliers
Lead validation of terminal sterilization suppliers
Provide technical guidance on product design
Provide technical guidance on process controls
Provide technical guidance on organizational capabilities
Drive adoption of advanced analytics
Drive adoption of digital environmental monitoring tools
Drive adoption of data-driven risk assessment approaches
Enhance contamination surveillance
Enhance trending across the network
Lead cross-site microbiological investigations
Oversee cross-site microbiological investigations
Develop systemic remediation efforts
Ensure robust root cause analysis
Ensure sustainable corrective actions
Maintain knowledge of global regulations
Maintain knowledge of guidance documents
Maintain knowledge of industry best practices
Support review of regulatory filings
Lead sterility assurance-related regulatory inspections
Support sterility assurance-related regulatory inspections
Engage directly with Health Authorities
Lead assessment of new regulations
Lead adoption of new regulations
Assess updated regulations
Adopt updated regulations
Ensure CMOs maintain inspection readiness
Ensure internal sites maintain inspection readiness
How You'll Work.
Team & Collaboration
Partnering with Product Development; Partnering with Materials Science & Technology; Partnering with Quality; Partnering with Internal Manufacturing; Partnering with External Manufacturing; Partnering with Operations; Partnering with Engineering; Cross-functional teams
Communication Scope
Executive reporting
Process & Methodology
Business planning, Roadmap planning
Full Job Description
**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: [careers.bms.com/working-with-us](https://careers.bms.com/working-with-us). **Position Summary** The**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 microbiolog
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