Cliff Sachs

Managing Consultant - Quality, Regulatory and Compliance Practice @Tunnell Consulting, Inc.

Performing Quality, Regulatory, and Compliance consulting activities for a premier life sciences consulting firm to enhance quality and operational excellence in the biotech and pharmaceutical industry. • Product Development Plan Quality Assurance Expert: Provided Quality Assurance expertise into risk assessment and gap analysis for the Product Development Plan for an advanced clinical stage product monoclonal antibody candidate. • QC Compliance Lead: Led Quality Control Compliance activities and staffing and providing EU Pre-Approval Inspection support for gene therapy company. • GMP QA Person-in-Plant: Acted as QA person-in-plant located at contract manufacturer for early-phase cell therapy company. • Regulatory Consultant: Provided regulatory consulting for pre-IND FDA Meeting for biotechnology company. • GMP Quality Assurance Lead: Led QA Department activities and staff and FDA Pre-Approval Inspection support for gene therapy company that obtained successful FDA approval of its first commercial product. • Quality Systems PAI Readiness Consultant: Performed Quality Systems gap assessment and remediation in support of PAI Readiness for commercial manufacture of biopharmaceutical company’s first commercial product. • Quality Assurance Organization Consultant: Provided support for organization of QA processes and procedures for start-up company specializing in gastrointestinal medicine in preparation for initiation of clinical manufacture. • Data Integrity Assessment Consultant: Performed laboratory data integrity assessments for global generic manufacturer at four US locations. • QA Commercial Readiness Consultant: Performed Cleaning Validation Assessment and technical review and coaching for Deviation Investigations in support of commercial readiness for the first BLA submission for South Korean based biologics contract manufacturer.