Christopher Hanff

Chris Hanff is an ASQ Certified Manager of Quality/ Organizational Excellence (CMQ/OE).

Mr. Hanff has over 17 years on-going experience in biopharmaceutical operations, quality systems, and has worked on an array of projects ranging from suite start-up, design, and commercialization to pharmaceutical manufacturing management. He has extensive experience in essential quality management systems oversight, design, and remediation, including under FDA sanctioned consent decree.

Chris consults for the pharmaceutical industry related to quality risk management, quality systems development and deployment, lean manufacturing, value stream mapping, metrics development, statistical analyses, compliance, TrackWise, DocCompliance and similar enterprise software solutions, aseptic processing, and manufacture. He has a wide range of product experience including biotechnology, sterile product, injectables, lyophilization, medical device, and active pharmaceutical ingredients (API).

Significant depth and breadth of experience as an architect of Quality Systems including: CAPA; Investigations; Complaints; Annual Product Review; Metrics & Trending; TrackWise EQMS; FDA mandated Consent Decree Remediation; Quality Risk Management.

• CMQOE
• Quality Systems senior management
• Management Review
• Operations Management
• Project Management
• Metrics control plan development, deployment
• Value Stream Mapping
• Lean Process champion
• Quality & Compliance Gap Analysis
• CAPA & Investigation Governance
• Nonconformance Board Chair
• Root Cause Analysis
• TrackWise system ownership
• Quality Risk Management program creator, director
• Protocol / SOP development
• Product Transfer
• Knowledge Management
• Training Delivery
• Process Development
• Facility-Suite Design & Start-up
• Consent Decree Remediation