Dennis Champagne

WORK HISTORY

EDUCATION

ABOUT DENNIS CHAMPAGNE

Vice President Quality and Compliance | cGxP Professional | Microbiologist | Quality Control | Quality Assurance | Aseptic Fill/Finish Leader | Expert in 503B | People Centered | Results-Driven Professional | Progressive LeaderA people-centered, results-driven professional with extensive experience as a progressive leader in quality control, quality assurance, and manufacturing within the pharmaceutical, 503B, medical device, and contract testing industries. Known for strategic leadership, commitment to operational excellence, and the ability to collaborate cross-functionally or work autonomously to achieve organizational goals. Skilled in aligning quality and manufacturing operations with the industry’s best practices to deliver consistently measurable outcomes. Renowned for expertise in aseptic processing, fill-finish operations, and FDA compliance management, leveraging a strong foundation in current Good Manufacturing Practices (cGMP). Adept at driving improvement initiatives, fostering high-performing teams, and ensuring regulatory compliance in dynamic environments. Contact information: email: s••••••••@gmail.com phone: 41••••••95Key Accomplishments: Five FDA Led Inspections with VAI Status (No warning letters) Seven CA Board of Pharmacy Inspections, all resulting in renewed license Implementation of document and training management systemThe following is a list of my key skills:Hard Skills:• Quality Compliance and Control• Quality Control Release Testing• Successful FDA Audits• Laboratory Test Development• Protocol and SOP Development • Negotiation (Experienced)• Value Stream Mapping• Root Cause Analysis• Project Planning• Supplier Quality Audits• Lean ManufacturingTechniques:• Process Optimization• Operations Management• Process ImprovementTools and Software:• Microsoft Office Suite• Trackwise• MasterControl