George H.

About George H.

A quality professional with 20 years of experience in the quality control arena.…

Experience

1. Associate Director Quality Control

   ImmunityBio, Inc.

   Feb 2022 — Present · Culver City, CA, US

   Manage testing that supports early phase to late-stage clinical and commercial programs- Establish policies and procedures to prepare early phase laboratory for FDA commercial readiness inspection that are complaint with GMP part 210, 211 and ICH Q7 requirements- Oversee internal testing for laboratories performing ELISA, Compendial, HPLC, CESDS, iCEF, Western Blot and Mycoplasma testing that supports both lot release and stability requirements- Initiate, manage and ensure timely closure for CAPAs, deviations, change controls for department- Author and execute method verification and method transfer protocols to support internalization of testing activities from CMOs and CTOs- Participate in regulatory audits by providing SME support for internal activities- Collaborate and oversee CMOs and CTOs to monitor manufacturing and testing activities supporting release and stability programs for Ad5 viral program- Leverage Veeva document management system to manage SOPs, Forms, Quality Improvement Plans, CAPA and deviations- Parter with Regulatory team to ensure BLA and IND filings are updated appropriately with relevant testing information- Develop and execute method validation/verification protocols along with associated reports to facilitate internalization of testing previously performed by contract laboratories- Provide budgets for current and future operations including strategy and plans for laboratory relocations and new laboratory implementation- Establish and track critical department KPIs to help identify gaps area performance/compliance and implement corrective actions to drive improvements- Lead investigations to ensure timely and effective closure for OOS, OOT and unexpected results- Interface with other departments (e.g, Manufacturing, Facilities, Engineering, Quality Assurance and Regulatory) to ensure achievement of department goals

Education

• Loyola Marymount University

  Bachelors Science