Jun Xue

Background

About Jun Xue

Accomplished Quality Assurance professional with a proven track record in the pharmaceutical and biotech industry. Experienced in developing, implementing, and optimizing Quality Management Systems (QMS) in compliance with FDA, EMA, ICH, and ISO standards. Expert in mapping all quality elements (60+ critical cGMP activities) with KPIs into the FDA cGMP six-system model, establishing a comprehensive quality dashboard for real-time tracking and analysis of quality system health. Ensures that all cGMP activities related to product quality, safety, and compliance are effectively managed and continuously improved. Adept at collaborating with cross-functional teams and external stakeholders to implement quality initiatives and maintain regulatory excellence. Extensive expertise in combination products across all development stages. A strategic problem solver committed to fostering a culture of quality excellence, patient safety, and scientific integrity in a fast-paced, highly regulated environment.