PHARMAFull-time
Sr Director, Microbiology
UNITED STATES (US)REMOTEPOSTED: 8/21/2026
PHARMAFull-time
HIRING ORGANIZATIONGILEAD SCIENCESTechnology
ROLE DEFINITION & RESPONSIBILITIES
Role Overview
Gilead Sciences is seeking a Senior Director, Microbiology to establish and execute the enterprise microbiology and sterility assurance strategy across global internal manufacturing sites and external contract manufacturing partners. In this executive remote role, you will define global standards for contamination control, lead health authority inspection interactions, and drive digital transformation and rapid microbiological method adoption across the organization.
Core Responsibilities
Enterprise Strategy & Governance: Establish and execute global microbiology and sterility assurance governance, defining corporate technical policies, quality standards, and operational best practices across all commercial and clinical manufacturing networks.
Sterility Assurance & Contamination Control Strategies (CCS): Provide strategic oversight of enterprise Contamination Control Strategies aligned with EU GMP Annex 1, governing aseptic processing, sterile/non-sterile manufacturing, biologics, cell and gene therapies (ATMPs), and clean utilities (water, HVAC, cleanrooms).
Microbiology Laboratory Oversight: Direct global laboratory programs covering environmental monitoring, sterility testing, bioburden, bacterial endotoxin testing (BET), mycoplasma testing, microbial identification, and method lifecycle validations.
Regulatory Compliance & Health Authority Interactions: Serve as the chief scientific authority representing the company during FDA, EMA, MHRA, and WHO regulatory inspections, pre-approval inspections (PAIs), and regulatory dossier authoring/defenses.
Risk Management & Investigations: Lead scientific root cause analyses for critical sterility excursions, media fill failures, and environmental monitoring deviations utilizing ICH Q9 quality risk management principles and statistical trending analytics.
Cross-Functional & Matrix Leadership: Partner with Global Manufacturing, Engineering, Validation, and Regulatory Affairs to guide facility expansions, tech transfers, new product introductions (NPIs), and supplier quality controls.
Technical & Digital Innovation Standards
Deep expertise in EU GMP Annex 1, ICH Q9/Q10, USP/EP compendia, and ISO standards.
Championing rapid microbiological methods (RMM), automated testing platforms, and predictive analytics for microbiological quality oversight.
Total Rewards & Benefits
Base salary range: $221,000 - $286,000 USD with eligibility for discretionary annual bonuses and equity/long-term incentives.
Comprehensive health, dental, vision, life insurance, paid time off, and executive wellness benefits.
REQUIRED VERIFIED SKILLS
Microbiology
Sterility Assurance
Contamination Control Strategy (CCS)
EU GMP Annex 1
Aseptic Processing
Environmental Monitoring
Quality Risk Management (ICH Q9)
Regulatory Inspections
Method Validation
Bioburden & BET
COMPENSATION & REWARDS
USD 2.2L - 2.9L per annum
ORGANIZATION CONTEXT & CULTURE
Gilead Sciences is actively hiring for this position.
INDUSTRY: Technology
RECOMMENDED TRAINING
1/4
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