Quality Management System (QMS) Design & Development - Accountable for the design, implementation, and continuous improvement of a robust, process-based Quality Management System across all GxP areas (GMP, GVP, GCP), including core processes such as Deviation, CAPA, Change Control, and Management Review. System Architecture & Digital Quality Infrastructure - Ensure organizational competency through the design and implementation of training programs and capability development initiatives for internal teams. Deep expertise in QMS design, eQMS platforms, data integrity governance, and global regulatory compliance across multiple GxP domains. Digital & System Competence - Familiarity with science IT systems, computerized system validation (CSV), and digital quality management tools in a regulated environment.
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