A pharmaceutical and biopharmaceutical professional with 15+ years of practical expertise in the development, integration, management, and improvement of quality management systems for GMP and technical processes. Having a thorough understanding of how quality systems can govern and improve lean, efficient, and productive GMP operations. Successive increases in responsibilities and multi-disciplinary duties allow me to have a broad perspective of manufacturing capabilities, global compliance standards, and how to integrate the two within an efficient and effective Quality System.
- Acting as Single Point of Contact for all quality related activities.
- Lead continuous improvement of quality processes associated to commercial drug manufacturing.
- Responsible to give instructions to the management on quality topics that relate to ongoing R&D and commercial products.
- Monitor Quality KPIs for trends and notify management of events requiring and immediate action.
- Support the Suppliers, CMO and CRO's quality management system, including external audit program.
- Ensuring site readiness for regulatory inspections and quality audits and supports during such events.
- Identify applicable regulations, procedures and respective training needs for the individuals.
- Oversee and approve the compilation of all dossiers (product, clinical trial, and facility) for materials and critical data.
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