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Lead the design and implementation of QMS and CSA frameworks, ensuring compliance with GxP regulations and overseeing quality management processes and software assurance.

The Senior QC Specialist conducts comprehensive QC reviews of analytical data to ensure compliance and integrity for drug substance and product programs, collaborating with Quality Assurance and Manufacturing teams.

The Associate Director, GxP Training leads the development and improvement of GxP training programs, ensuring compliance with regulations and integrating quality performance data. They partner cross-functionally to align training with quality objectives while driving continuous improvement initiatives and overseeing training operations and documentation.

Lead global GCP quality strategy and oversight for sponsor and outsourced clinical trials. Develop audit strategy, provide GCP guidance, make final quality decisions, manage vendor/CRO risks, ensure inspection readiness, and drive continuous improvement of GCP QMS and training to protect patient safety and data integrity.

The Data Scientist will enhance the platforms, develop tools for clinical research, and ensure reliability of analytical solutions using software engineering best practices.

The Principal Data Scientist will lead the development of AI-powered data science tools, collaborating with cross-functional teams to enhance clinical research and optimize trials. Responsibilities include designing scalable solutions, ensuring software reliability, and communicating insights effectively.

The Associate Director/Director of Biostatistics provides statistical support for clinical drug trials, oversees CRO activities, and ensures regulatory compliance for data submissions.

The role involves leading statistical programming for clinical studies, ensuring compliance with CDISC standards, collaborating across teams, and enhancing programming efficiency through automation.

The Associate Director, Trial Master File oversees eTMF governance for clinical trials, ensuring compliance, quality, and timeliness in processes to support inspections and collaboration across functions.

The Sr. Director of Commercial Supply Chain leads supply chain operations, ensuring steady drug supply, demand forecasting, and cross-functional collaboration for clinical and commercial programs.