Joseph Delfs

Background

About Joseph Delfs

20+ years of experience in the pharmaceutical and biotechnology industries with 15+ years in Quality Assurance. Experienced in the quality oversight of activities related to the manufacture and testing of small molecule pharmaceuticals and large molecule biologics within clinical and commercial facilities. In-depth knowledge of industry regulations, including but not limited to 21 CFR Part 11, Good Manufacturing Practices (21 CFR 210 and 211), Good Laboratory Practices (21 CFR 58), and Good Clinical Practices (21 CFR 312). Quality Assurance (QA), GxP, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Quality Management Systems (QMS), Electronic Quality Management System Solutions (eQMS), Computer System Validation (CSV), Commissioning, Qualification, and Validation (CQV), Data Integrity (DI), Change Controls (CC), Investigations, Corrective and Preventive Actions (CAPAs), Training, Standard Operating Procedures (SOPs), Policies, Work Instructions (WIs), Forms, Templates, Internal, External, and Vendor Audits, Quality Risk Management (QRM), Pre-Approval Inspection (PAI), Biologics License Application (BLA), Investigational New Drug Application (IND), Key Performance Indicators (KPIs)