Head Of Quality Strategy For Computerized Systems (All Genders)

The purpose of the Head of Quality Strategy for Computerized Systems (CS) role is to lead and establish the strategic direction necessary to ensure the integrity and compliance of quality management systems associated with R&D computerized systems and Artificial Intelligence (AI) technologies. This position is dedicated to driving continuous improvement initiatives within the QA framework, fostering a culture of quality across the organization, and ensuring that all systems adhere to regulatory standards while implementing risk-based validation strategies to maintain the highest quality standards.

This role directs and supports the global Quality Strategy team in executing QA activities related to Computerized Systems (CS) and Artificial Intelligence (AI), including managing audits and inspections for R&D CS and AI technologies. This person is accountable for defining and executing of GLP, GCP and GVP compliant, efficient validation & lifecycle management strategy for global R&D GxP systems & AI; identifying & driving continuous improvement of quality processes for computerized systems based on industry trends, metrics, audit findings, root-cause analyses and stakeholder feedback; continuously assess and refine strategic approaches to drive necessary changes in R&D Computerized Systems and AI, ensuring compliance with regulatory requirements and alignment with industry best practices.

The Head of Quality Strategy for Computerized Systems collaborates with executives and business partners to identify risk areas in Computerized Systems and AI, facilitate prompt communication, and drive effective issue resolution.

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