Andrew Micali
Global Training Systems Leader | LMS Administration Expert (ComplianceWire, Veeva, Cornerstone) | GxP Compliance | Digital Learning & Instructional Design | 21 CFR Part 11 / Annex 11
- Role
- Learning Management System Administrator at USDM Life Sciences
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Andrew Micali
I’m a Global Training Systems & GxP Compliance Leader with 15+ years managing enterprise LMS platforms, digital learning ecosystems, and inspection-ready training programs across pharma, biotech, and medical device environments. I specialize in LMS administration (Veeva, ComplianceWire, Cornerstone/SABA, ZenQMS), global training governance, role-based curricula, and SCORM/xAPI-based learning content.I build scalable, validated learning systems that meet 21 CFR Part 11, EU Annex 11, FDA, EMA, and MHRA expectations. I’ve led global councils, standardized training processes across regions, and partnered with Quality, HR, EHS, and Operations to drive learning strategy and continuous improvement.My focus: creating efficient, compliant, user-friendly training ecosystems that elevate workforce capability and support organizational excellence.
Experience
Learning Management System Administrator
May 2023 — Present · Santa Barbara, CA, US
Education
New York University - Polytechnic School of Engineering
Pre-Medicine/Pre-Medical Studies
Skills
- Pharmaceutical Industry
- Sop
- Fda
- Life Sciences
- Lean Manufacturing
- Software Documentation
- Quality Control
- Gmp
- Biotechnology
- R&D
- Quality System
- V&V
- Six Sigma
- Gxp
- Quality Auditing
- 21 Cfr Part 11
- Clinical Trials
- Glp
- Gcp
- Training
- Medical Devices
- Capa
- Regulatory Submissions
- Technology Transfer
- Lims
- Iso 13485
- Regulatory Affairs
- Lifesciences
- Change Control
- Quality Assurance
- Cross-Functional Team Leadership
- Validation
- Computer System Validation
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