Norm Card

Background

About Norm Card

Quality Assurance Project Leader with over 25 years of cGMP experience in the Vaccine/Pharmaceutical (Biologics) industry in both the Commercial and R&D departments. Quality oversight of third party organization documents, procedures and processes involved in the development of products for R&D. A liason between R&D Scientific Leaders and RA for implementing Quality by design approach of product development through to submission. Ensures compliance with regulatory requirements of ICH, USP, EP and FDA guidelines. Authoring Quality Assurance Agreements with third parties. Auditor of third party organizations (Due diligence, Routine GMP). Batch release of Clinical trial and Registration batch material. Interactive manager with strong analytical background and experience managing assay validations and transfers. Lead investigator for deviations, an effective change control leader and a CAPA owner for corrective actions.