Healthcare Quality & Regulatory Automation Analyst

About the role

Position summary Act as a technical expert in healthcare quality and regulatory analytics. Combine advanced quantitative analysis, data engineering, and quality system expertise to build stakeholder-specific reporting, develop AI-enabled quality tools, and integrate/manage third-party quality applications to support compliance, continuous improvement, and executive decision-making. Key responsibilities (primary) - Perform advanced quantitative data analysis: build statistical and machine learning models for trend detection, root-cause analysis, forecasting, anomaly detection, and risk stratification - Design, build, and maintain stakeholder-specific dashboards and reports (executive, regulatory) using Power BI tools and data visualization best practices; deliver actionable insights and data storytelling. - Develop and maintain quality tools and automations using AI/ML/LLM technologies (NLP for document classification/summarization, automated quality checks, predictive analytics, chat assistants for SOP/QMS guidance). - Lead integration and lifecycle management of third-party quality software: requirements gathering, vendor coordination, configuration, data integration, testing, release coordination, and ongoing support. - Utilize current and emerging technologies in evaluating trends to business models and healthcare quality processes - Develop insights and translate information into actionable initiatives to ensure business outcomes - Lead and support projects through the application of technical expertise including conceptualization, planning, design, implementation and support of quality assurance processes, systems, and quality technology solutions - Evaluate and monitor healthcare quality processes and systems to identify areas for continuous improvement and transformation ensuring global excellence - Initiate and lead the development of reports for key stakeholders, including executive management, using data storytelling and visualization. - Develop and execute tools to enhance services and deliver training for internal customers or vendors on analytics outputs, tools, and integrated systems. - Gather and consolidate regulatory and business requirements into convert them into technical specifications and implement monitoring to ensure ongoing compliance with company's internal policies and relevant regional and local regulations. - Develop and maintain data validation, models, and metadata; routinely assess model performance and recalibrate as required. - Lead end-to-end analytics projects: planning, stakeholder alignment, implementation, and post-implementation reviews; document methods and SOPs. - Support audit readiness and provide analytics-driven evidence for regulatory submissions, inspections, and internal quality reviews. - Identify opportunities for process improvement and automation in quality workflows, pilot new technologies and scale successful solutions. Additional responsibilities (as needed) - Provide subject-matter expertise for cross-functional programs and global initiatives. - Manage vendor relationships and service-level expectations for third-party tools. - Participate in career progression and mentoring for junior analysts. Required skills and experience - Bachelor's degree in Statistics, Data Science, Biostatistics, Engineering, Computer Science, Information Technology, Healthcare Analytics, or related field (or equivalent experience). - Strong quantitative and statistical skills; proficiency in data science libraries and tools - Experience building dashboards and visualizations with tools such as Power BI, Tableau, Looker, or equivalent. - Hands-on experience integrating and managing third-party quality/GxP systems (MasterControl, Synthesis, ServiceNow) or similar QMS/issue tracking platforms. - Experience working with cloud platforms, databases (SQL, NoSQL), ETL tools, and APIs. - Practical experience applying AI/ML and prompt engineering for LLMs to automate quality processes, extract insights from unstructured documents, or create assistant workflows. - Strong data validation, data modeling, and data governance understanding. - Excellent communication and data storytelling skills; able to translate technical findings into concise recommendations for executives. - Experience in a regulated environment (healthcare, life sciences, medical devices, or similar) strongly preferred. - Demonstrated ability to work cross-functionally and manage vendor/IT relationships. Preferred - Certifications in data analytics, machine learning, or quality management. - Prior experience with global operations or multi-regional regulatory frameworks. Level expectations and experience guidelines - 3-4 years relevant experience; independently manages projects and provides expert input, recognized expert, leads complex programs with high autonomy. Core competencies - Analytical thinking, accuracy, attention to detail, numerical skills. - Pla

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