About The Position

The R&D Quality Analytics Senior Specialist will design, develop, and maintain analytics solutions that enhance visibility into RDQA processes, inspection readiness, study/program quality, and compliance metrics and trends. This role converts complex functional area (i.e., GCP, GLP, GVP, Research, and Real-World Evidence) and quality datasets into intuitive dashboards and reports that support proactive quality oversight and data-driven decision‑making. This individual will gather requirements and support RDQA teams in analytics-based projects and collaborate across analytical / technical business functions to implement improvements to align quality needs and objectives with strategic corporate goals and initiatives. The ideal candidate will have a strong bacgkround in Quality Data (deviations, CAPA, etc..), ability to build data models, maintain/build data warehouse, experience with Power BI for Visualization and Snowflake.

Requirements

  • Advanced proficiency in Power BI (Desktop & Service), including DAX, data modeling, and Power Query.
  • Strong SQL skills and fluency working with Snowflake tables.
  • Experience working with clinical, R&D, and quality‑related datasets.
  • Ability to gather technical requirements and synthesize data into actionable insights for diverse stakeholders.
  • Strong communication skills to clearly convey complex data findings to technical and non‑technical audiences.
  • Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions.
  • Experience supporting quality processes and systems (e.g., deviations, audit management, inspection readiness) strongly preferred.
  • Bachelor’s degree in Life Sciences, Computer Science, Engineering, Data Analytics, or a related field.
  • 5+ years of relevant work experience (developing BI solutions, or an equivalent combination of education and experience).

Nice To Haves

  • Experience working in GxP, R&D Quality, or regulated biotech/pharma environments is a plus.

Responsibilities

  • Develop, optimize, and maintain Power BI dashboards and data models that support R&D Quality programs and projects.
  • Partner with R&D Quality leaders, QA leads, and cross functional SMEs to define analytical requirements and key performance indicators.
  • Identify, analyze, and interpret trends or patterns in complex data sets for visualizations.
  • Validate/verify data accuracy and perform quality checks to ensure compliance with data governance and R&D Quality standards.
  • Support data acquisition, ingestion and transformation of data for scalable growth.
  • Support preparation and visualization of inspection related data for regulatory agencies (e.g., FDA, EMA).
  • Maintain controlled documentation, dashboard inventories, and version tracking for all BI assets.
  • Support analytics implementation services (i.e., analytics Center of Excellence) including communication, change management, user documentation, and data literacy.
  • Identify and implement continuous improvement opportunities to elevate data driven decision making in R&D Quality.
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