Executive Director, Microbiology Quality, Sterility Assurance

Bristol Myers Squibb

. Define, own, and drive BMS's Global Sterility & Microbiology Assurance Strategy .

Posted 9/15/2026full-timePrinceton • New Jersey • United StatesLead💰 $260,860 - $316,097 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Global Sterility and Microbiology Assurance Strategy, with a strong focus on contamination control, aseptic assurance, and regulatory compliance. Proven ability to lead and develop teams while driving continuous improvement and maintaining inspection readiness across pharmaceutical and biopharmaceutical environments.

Highest-signal resume keywords

Global Sterility Assurance StrategyAseptic AssuranceRegulatory CompliancePeople ManagementContamination Control

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Aseptic ControlMicrobiological ControlsKPI AnalysisRoot Cause AnalysisRegulatory Inspection SupportData-Driven Contamination SurveillanceCAPA DevelopmentTerminal Sterilization ValidationTrend AnalysisQuality Assurance

Soft Skills

Executive PresenceInfluencing SkillsTeam DevelopmentCommunication SkillsCoaching and Mentoring

Tools & Technologies

Digital Environmental MonitoringQuality Management SystemsStatistical Analysis ToolsRegulatory Filing SystemsContamination Surveillance Tools

Industry Keywords

FDAEMAMHRATGABiopharmaceuticalPharmaceuticalMedical DeviceCMO PartnershipsHealth Authority RegulationsIndustry Standards

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Bachelor's degree in a Scientific Discipline, preferably Microbiology, Life Sciences, or Biological Sciences
Significant and progressive experience in aseptic or bioburden control manufacturing environments, including production, QA, and/or validation
Demonstrated successful results in a Health Authority-regulated environment, such as FDA, MHRA, EMA, or TGA
10+ years of people management experience
Track record of leading large, globally distributed teams
Proven experience in aseptic/sterility assurance across pharmaceutical, biopharmaceutical, or medical device industries
Experience leading or supporting regulatory inspections and PAIs, including direct engagement with FDA, EMA, and MHRA as the senior technical SME
Ability to lead through influence in a complex, global matrix organization
Executive presence and ability to communicate and influence at VP/SVP/C-Suite level
Advanced degree (MS, MPhil, PhD, MTD) in Microbiology, Industrial Microbiology, Clinical Microbiology, or Bacterial Toxicology preferred
Experience working within or managing CMO partnerships in a quality assurance capacity preferred
Experience in due diligence for CMO onboarding and new product launches preferred
Experience with industry standard-setting activities through PDA, ISPE, PhRMA, or equivalent organization preferred
Ability to travel 30–50%

Benefits

Comp & perks

Additional discretionary incentive cash and stock opportunities
Wellbeing support
Retirement and financial protection benefits
Medical, dental, vision, life and disability insurance offerings
Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees
11 paid company holidays
160 hours of paid vacation annually for eligible new hires
3 optional holidays for eligible non-exempt, RayzeBio, and Puerto Rico employees
Paid sick leave
Up to two paid volunteer days per year
Summer hours flexibility
Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
Annual Global Shutdown between Christmas Day and New Year's Day
Workplace accommodations/adjustments and ongoing support for people with disabilities