Director, Global Microbiology Governance – Oversight

BeOne Medicines

. Provide global strategic leadership and governance for contamination control strategy across manufacturing sites .

Posted 11/6/2026full-timeRemote • United StatesLead💰 $168,000 - $228,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in microbiology within cGMP-regulated environments, ensuring compliance with FDA, EMA, and USP/EP standards while leading global contamination control strategies and microbiological practices. Proven ability to drive operational excellence and technical leadership in complex microbial investigations and regulatory submissions.

Highest-signal resume keywords

Microbiology ExpertiseRegulatory ComplianceAseptic ProcessingTechnical WritingAnalytical Troubleshooting

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

MicrobiologyContamination ControlRoot-Cause AnalysisEnvironmental MonitoringCAPA ImplementationMicrobial TestingCleanroom QualificationRegulatory SubmissionsQuality StandardsTechnical Leadership

Soft Skills

Attention to DetailLeadershipStrategic ThinkingCollaborationInfluence

Tools & Technologies

Microsoft 365LIMSComputerized Laboratory Systems

Industry Keywords

CGMPFDAEMAUSP/EPBiopharmaceuticalPharmaceutical Manufacturing

About the role

Key responsibilities & impact

Provide global strategic leadership and governance for contamination control strategy across manufacturing sites
Establish standards and ensure consistent implementation and regulatory compliance
Ensure operations adhere to FDA, EMA, cGMP, and USP/EP compendial standards
Act as a subject matter expert during regulatory inspections and audits
Establish and maintain global microbiology standards and governance for microbial limits, sterility, endotoxin, and bioburden testing
Drive harmonization of microbiological practices across the global network
Provide technical leadership for complex or high-risk microbial investigations, including OOS results, Environmental Monitoring excursions, and contamination events
Lead root-cause analysis and implement effective CAPA
Identify emerging microbiological and regulatory risks and translate them into global Quality standards
Build and lead a global microbiology community of practice or technical network
Provide strategic microbiology input to new facilities, technology transfers, capital projects, and product introductions
Partner with Manufacturing, R&D, and Engineering to assess microbiological risks during process changes and facility modifications
Lead new technology implementation and Operational Excellence projects
Provide leadership through global influence, governance, and expertise

Requirements

What you’ll need

Bachelor’s degree and 10+ years of microbiology experience in a cGMP-regulated biopharmaceutical or pharmaceutical manufacturing environment required
Master’s degree and 7+ years of Biopharmaceutical experience preferred
Doctoral Degree and 5+ years of Biopharmaceutical experience
Strong proficiency with Microsoft 365 and relevant laboratory systems, including LIMS
Deep knowledge of aseptic processing, cleanroom qualification, environmental monitoring, and computerized laboratory systems (LIMS)
Strong analytical troubleshooting skills
Rigorous attention to detail
Excellent technical writing skills for regulatory submissions and investigation reports
Knowledge of FDA, EMA, cGMP, and USP/EP compendial standards
Up to 20% travel

Benefits

Comp & perks

Annual bonus plan eligibility for non-commercial roles
Incentive compensation plan eligibility for commercial roles
Discretionary equity awards
Employee Stock Purchase Plan
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness