Our partner is focused on developing innovative treatments in oncology, rare diseases, and neuroscience. Their goal is to address unmet medical needs by providing targeted therapies that improve patient outcomes and enhance the quality of life for those with complex conditions.
This critical hire transformed the quality function, ensuring compliance, efficiency, and readiness for product launch in a global, virtual environment. They developed a cohesive vision for quality assurance, quality control, and GxP compliance, addressed leadership gaps, and united geographically dispersed teams to achieve corporate objectives. With oversight of pre- and post-licensure inspections, vendor management, and regulatory requirements, they played a pivotal role in preparing for the launch of a sterile injectable in Europe, ensuring alignment with international standards and operational excellence under tight timelines.
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