Supply Chain Subject Matter Expert (SME)

Brillient Corporation is seeking a highly analytical and detail-oriented professional to support data analytics and operational improvement initiatives within a dynamic regulatory environment. This role will focus on developing and enhancing cross-operational dashboards, identifying data-driven insights, and improving system interoperability to strengthen incident, recall, and shortage operations. The ideal candidate will have experience in data systems analysis, process improvement, and leveraging advanced tools—including artificial intelligence—to drive efficiency and informed decision-making.

• Review and assess the Online Reporting Analytics and Decision Support System (ORADSS) and other potential resources, including artificial intelligence tools, to identify efficient solutions for data management, tracking, and analytics.
• Analyze and evaluate system interoperability with existing data management platforms, including the Recalls Enterprise System (RES) and Compliance Management System (CMS).
• Design and propose processes and system solutions that enable identification of operational gaps and opportunities for improvement.
• Develop strategies to enhance surveillance and targeting of firms involved in the manufacture and distribution of unsafe or ineffective drug products.
• Support the implementation of new processes and systems, including providing staff training and guidance.
• Create, track, and maintain cross-operational dashboards for incidents, recalls, and shortages.
• Monitor and evaluate the effectiveness of implemented processes and systems, recommending adjustments as needed.

Required Education and Qualifications:

• Bachelor's Degree and minimum four (4) years' related experience
• Experience implementing program or project requirements through to completion, including coordinating with multiple organizations across the FDA to ensure information gathered from stakeholder is acceptable for program or project implementation.
• Experience supporting and managing supply chain risk analytics programs (e.g., descriptive and predictive analysis)
• Experience in data science (e.g., Artificial Intelligence or Machine Learning), risk management, and data management.
• Experience organizing project teams and effectively coordinating communication with team members.

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