Carlos Lugo

Senior Vice President, Quality and Regulatory Affairs @Revance

San Francisco, CA, US
MOBILE NUMBERS
+19•••••••16

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WORK HISTORY

Jun 2025 — Present

Senior Vice President, Quality and Regulatory Affairs @Revance

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EDUCATION

1989 — 1994

Universidad de Puerto Rico

BSChE, Engineering

SKILLS

Contract ManufacturingSix SigmaGxpQuality AuditingAseptic ProcessingDesign ControlRoot Cause AnalysisRemediationChange ControlBiotechnology21 Cfr Part 11GlpDrug DeliveryFda GmpLimsSterilizationRegulatory AffairsCleaning ValidationSupplier QualityIso 14971Iso 13485Computer System ValidationLaboratoryBiopharmaceuticalsQuality AssuranceGampQuality ControlGmpDmaicRegulatory SubmissionsQuality ManagementIsoPharmaceutical IndustrySopFdaPharmaceuticsQuality SystemV&VProcess SimulationMinitab

ABOUT CARLOS LUGO

With extensive experience across Quality Assurance, Quality Control, Regulatory, Compliance, Manufacturing and Validation, I lead a team of professionals dedicated to ensuring the highest standards of quality and compliance in the biopharmaceutical industry. With over 30 years of experience in the field, I have a proven track record of developing and implementing effective quality management systems, managing regulatory affairs, and overseeing clinical and commercial manufacturing operations.My expertise spans across various aspects of quality assurance, including process validation, quality control, and risk management. I have successfully led multiple organizations (big and small) as well as multiple projects involving new product launches, facility expansions, and technology transfers, ensuring seamless execution and compliance with regulatory requirements. My goal is to foster a culture of excellence and continuous improvement within the organization, while delivering high-quality products that meet the needs of patients and stakeholders.

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