Senior Director, Microbiology

Gilead Sciences

Senior microbiology executive leading enterprise sterility assurance and contamination control. Guiding Gilead’s biopharmaceutical development and manufacturing of medicines for serious diseases.

Posted 8/20/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $221,000 - $286,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Microbiology, Sterility Assurance, and Contamination Control within regulated environments, ensuring compliance with global regulatory standards and driving operational excellence. Proven ability to lead complex global teams and influence technical decision-making while fostering innovation and quality.

Highest-signal resume keywords

Microbiology ExpertiseSterility AssuranceContamination Control Strategy DevelopmentRegulatory Compliance (FDA, EMA, WHO)Quality Risk Management (ICH Q9)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Aseptic ProcessingEnvironmental MonitoringMicrobial Risk AssessmentMethod Validation and VerificationStatistical AnalysisPredictive AnalyticsContamination PreventionMicrobial IdentificationBioburden TestingBacterial Endotoxin Testing

Soft Skills

LeadershipMentorshipCollaborationStrategic OversightCommunication

Tools & Technologies

Cleanroom DesignHVAC SystemsQuality Management SystemsAutomation TechnologiesAdvanced Analytics

Industry Keywords

Pharmaceutical MicrobiologyBiologicsBiotechnologyMedical DeviceEU GMP Annex 1ISO Microbiological StandardsICH Quality GuidelinesPharmaceutical Quality Systems (ICH Q10)

Tech Stack

Tools & technologies

Airflow

About the role

Key responsibilities & impact

Establish and execute the enterprise microbiology and sterility assurance strategy
Develop and maintain the global governance framework for microbiology, contamination control, and sterility assurance programs
Define global microbiological and sterility assurance standards, technical policies, procedures, and best practices
Advise senior leadership on microbiological risk, contamination control, sterility assurance, and emerging regulatory expectations
Drive operational excellence, scientific innovation, and digital transformation in microbiology laboratories and contamination control programs
Provide strategic oversight of enterprise Contamination Control Strategies in accordance with EU GMP Annex 1 and global regulatory expectations
Oversee cleanroom design, classification, qualification, airflow visualization, HVAC systems, personnel qualification, gowning programs, material and personnel flows, and contamination prevention
Ensure environmental monitoring, utility monitoring, aseptic process simulation, and contamination control programs are scientifically justified, risk-based, and globally harmonized
Lead microbial risk assessments and contamination investigations for critical manufacturing events
Provide strategic oversight of enterprise microbiology laboratory operations, including environmental monitoring, sterility testing, bioburden testing, bacterial endotoxin testing, microbial identification, mycoplasma testing, antimicrobial effectiveness testing, rapid microbiological methods, method validation and verification, and method lifecycle management
Ensure laboratory programs maintain scientific integrity, data integrity, and regulatory compliance while promoting automation, advanced analytics, and emerging technologies
Ensure compliance with FDA, EMA, MHRA, WHO, PIC/S, ICH, ISO, USP, EP, and other global regulatory requirements
Provide executive oversight for deviations, investigations, CAPAs, change controls, quality risk assessments, validation strategies, and technical justifications
Represent the organization during regulatory inspections, customer audits, due diligence activities, and health authority inspections
Support regulatory submissions, product filings, agency responses, and post-marketing commitments with microbiological expertise
Monitor evolving regulatory expectations and implement improvements across the enterprise
Lead scientific evaluation of microbiological events, contamination investigations, environmental monitoring excursions, sterility and aseptic processing simulation failures, utility excursions, and product impact assessments
Apply scientific principles and quality risk management methodologies to determine root cause, product impact, and corrective actions
Establish microbial trending strategies using statistical analysis and predictive analytics
Collaborate with Global Manufacturing, Quality Operations, Facilities, Engineering, Validation, Technical Development, Supply Chain, Procurement, and Regulatory Affairs
Support facility design and expansion, technology transfers, new product introductions, manufacturing robustness, supplier microbiological controls, and contamination prevention across the product lifecycle
Lead a global microbiology organization focused on scientific excellence, operational performance, and continuous improvement
Develop technical capability through mentorship, coaching, succession planning, training, and technical development
Foster quality, accountability, innovation, and inspection readiness
Lead matrixed global teams and influence technical decision-making across business units and manufacturing sites

Requirements

What you’ll need

Bachelor’s degree with 14+ years of experience, or PhD, MS, or equivalent advanced degree with 12+ years of experience in Microbiology, Molecular Biology, Biological Sciences, or related scientific discipline
Minimum of 12+ years of progressive experience in pharmaceutical microbiology, sterility assurance, or contamination control within regulated pharmaceutical, biologics, biotechnology, or medical device environments
Extensive experience supporting global sterile manufacturing operations and aseptic processing
Expertise in FDA, EMA, MHRA, WHO, and other global GMP regulations
Expertise in EU GMP Annex 1
Expertise in USP microbiology chapters
Expertise in ICH Quality Guidelines
Expertise in ISO microbiological standards
Expertise in Quality Risk Management (ICH Q9)
Expertise in Pharmaceutical Quality Systems (ICH Q10)
Expertise in aseptic processing
Expertise in contamination control strategy development
Proven success leading regulatory inspections and executive interactions with global health authorities
Demonstrated leadership with large, complex, global matrixed organizations

Benefits

Comp & perks

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical insurance
Company-sponsored dental insurance
Company-sponsored vision insurance
Company-sponsored life insurance
Reasonable accommodation for applicants with disabilities