Carlos Lugo

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.

Experience

1. Senior Vice President, Quality and Regulatory Affairs

   Revance

   Jun 2025 — Present

Education

• Universidad de Puerto Rico

  BSChE, Engineering

  1989 — 1994

Skills

• Contract Manufacturing
• Six Sigma
• Gxp
• Quality Auditing
• Aseptic Processing
• Design Control
• Root Cause Analysis
• Remediation
• Change Control
• Biotechnology
• 21 Cfr Part 11
• Glp
• Drug Delivery
• Fda Gmp
• Lims
• Sterilization
• Regulatory Affairs
• Cleaning Validation
• Supplier Quality
• Iso 14971
• Iso 13485
• Computer System Validation
• Laboratory
• Biopharmaceuticals
• Quality Assurance
• Gamp
• Quality Control
• Gmp
• Dmaic
• Regulatory Submissions
• Quality Management
• Iso
• Pharmaceutical Industry
• Sop
• Fda
• Pharmaceutics
• Quality System
• V&V
• Process Simulation
• Minitab