Head of Quality
With over 15 years of Quality Management experience mentoring managers, supervisors, quality assurance specialists, engineers, and analytical chemists, Celeste O’Connor, has over 23 years of Quality Management System, (QA/QC/Validation) experience in the pharmaceutical industry. She demonstrates excellence in quality by example, to meet regulatory internal standards and holds an ASQ Certified Quality Auditor (CQA) Certification since 1999. She directs the Quality Assurance Department for a contract manufacturing for pre-clinical to commercial drugs and biologics. She is responsible for presenting the quality system, to regulatory agencies and customer auditors. Celeste creates and delivers Quality Management Review meeting presentations and KPI tracking. She also maintains site compliance to ICH Q7, CFR 210 and 211, and applicable regulatory standards, as well as, generates annual product quality reviews. She is responsible for key Quality System: batch release, deviation, CAPA, internal audits, change control, and laboratory OOS investigations. Celeste has extensive experience in hosting audits for worldwide regulatory authorities including FDA, EU, Health Canada, and Anvisa Central and South Americas. She led the BioMARC inspection and readiness program in 2015, and managed a regulatory inspection in 2016 with no form 483 observations. She has a Bachelor of Science in Biology, from Northeastern University.