Vice President & Business Management Services Director
Shane SnoebergerMBA, ASQ CQE
Quality and operations leader, certified quality engineer and Lean Six Sigma Black Belt with deep DEA registration expertise.
- Operations
- CAPA
- DEA
- Validation
- Due Diligence
20+ years in FDA- and DEA-regulated industry
Background
Shane Snoeberger is a quality assurance and operations expert with more than 20 years of combined experience in FDA- and DEA-regulated industries. He is a certified quality engineer (CQE) and a Lean Six Sigma Black Belt, and serves as Vice President of xFDA Investigators, LLC as well as Business Management Services Director.
He served in the United States Marine Corps, managing QA/QE for aviation electronics and validation systems at Air Station Miramar in San Diego, assuring compliance with applicable government standards. In industry he has worked with pharmaceutical and medical device manufacturers as VP of Quality, Director of Operations, Quality Engineer (SME) and QA/Compliance Manager, and as a compliance consultant on quality systems, remediation programs and due diligence audits.
His expertise spans project management, technical engineering, validation, production and process controls, electrical and mechanical failure analysis, CAPA, and Lean Six Sigma manufacturing. He is known for writing and remediating NCMRs, deviation investigations and CAPAs grounded in risk management and trend analysis, and he conducts GMP, QMSR and DEA compliance audits.
What Shane does on an engagement
- GMP, QMSR and DEA compliance audits
- DEA-regulated products and DEA state registrations
- Deviation, NCMR and CAPA remediation on a risk basis
- Production and process controls, failure analysis
- Due diligence audits and operational readiness
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