Lizauri Hernandez

About Lizauri Hernandez

As an accomplished Senior Quality Management Systems Leader, I bring over a decade of experience in developing and implementing advanced quality frameworks that drive compliance, operational efficiency, and regulatory alignment in GxP environments. Specialties Quality Management Systems (QMS) Environmental Monitoring (EM) Data Analysis & Reporting Quality Assurance & Control Process Validation Regulatory Compliance Computer System Validation (CSV) Laboratory Systems Development Clinical & Commercial ManufacturingMy approach centers around building systems that are not only robust but scalable—ensuring that your organization can maintain high standards of quality and compliance across every stage of growth. Key Strengths √ Quality Management Expertise:I have a proven track record of establishing end-to-end Quality Management Systems (QMS) that ensure regulatory compliance from the ground up, particularly in facility construction and start-ups. My work includes designing effective Quality Assurance (QA) and Quality Control (QC) sampling programs, as well as Environmental Monitoring (EM) protocols.√ Driving System Optimization & Compliance:I’ve spearheaded the implementation and optimization of global quality platforms, such as Veeva Vault, where I oversaw the full system validation in under 90 days with zero deviations. My leadership in change control, deviation management, and CAPA processes has enhanced the governance of QMS and laboratory systems globally.√ Training & Development Leadership:A cornerstone of my strategy has been fostering a culture of continuous improvement through education. I have developed training modules and work instructions that help teams understand and comply with QMS processes, increasing both user engagement and system navigation success rates.√ Strategic Leadership in Quality Systems:From creating insightful dashboards using Power BI to fostering data-driven decision-making, I’ve equipped senior management teams with the tools they need to oversee critical processes. My strategic plans align operational activities with high-level corporate objectives, ensuring sustainable growth and compliance.Let\'s Connect!

Experience

1. Associate Director Qa - Compliance

   Eli Lilly and Company

   Mar 2025 — Present · Pleasant Prairie, WI, US

   Leader of the QA Compliance (Central QA) organization at Lilly Kenosha County site. Responsible for deviation, CAPA, QA for QC, Change Management, Quality Engineering-FUME, Complaints, Document Control and One QMS programs at a parenteral manufacturing facility.

Education

• University of Puerto Rico-Mayaguez

  Bachelor of Science, Chemical Engineering

Skills

• Validation
• Pharmaceutical Industry
• Change Control
• Quality System
• Gmp
• Quality Assurance
• Biotechnology
• Training
• V&V
• Fda
• Cross-Functional Team Leadership
• Glp
• Vaccines
• Technical Writing
• Technology Transfer
• Document Management
• 21 Cfr Part 11
• Computer System Validation
• R&D
• Regulatory Affairs
• Sop
• Fda Gmp
• Capa
• Biopharmaceuticals
• Manufacturing
• Training Delivery
• Gxp
• Lims
• Cleaning Validation
• Quality Auditing
• Chemical Engineering
• Validation Maintenance
• Periodic Review
• Bacterial Vaccines
• Cleaning Valida
• Vmp
• Project Management
• Learning Management Systems
• Facilitation
• Edms