Joseph Delfs
Experienced Quality Professional in the Pharma and Biotech Industries
- Role
- Senior Principal Auditor at Eli Lilly and Company
- Location
- Mesa, AZ, US
- LinkedIn followers
- 500 followers
About Joseph Delfs
25+ years of experience in the pharmaceutical and biotechnology industries with 20+ 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)
Experience
Senior Principal Auditor
May 2024 — Present
Schedule, prepare, conduct, and report audits and assessments of GMP operations both internally and externally to assess the level of compliance with company standards, polices, practices, and procedures and current regulations and guidelines.Participate in or lead the preparation and/or review of standards, policies, procedures, and guidelines that are used to establish quality requirements.Prepare organizational metrics and trending of audit findings.Lead divisional improvement efforts. Support training and qualification of other auditors.
Education
Stevens Institute of Technology
MS, Management
2007 — 2010
Stevens Institute of Technology
BE, Chemical Engineering
1994 — 1998
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