Principal Scientist ensuring data quality for R&D Data Science at Johnson & Johnson. Leading quality initiatives and collaborating with cross-functional teams in innovative medicine.
Responsibilities
Develop and maintain a data quality management framework aligned with GxP, FAIR, and enterprise principles.
Define data quality dimensions (accuracy, completeness, consistency, timeliness, validity, integrity, and lineage) and establish measurable KPIs.
Partner with Data Governance, Knowledge Management Global Development, Regulatory and Master Data Management (MDM) teams to ensure traceability and alignment of data quality standards across domains.
Contribute to data stewardship, defining ownership and escalation procedures for quality issues.
Lead data validation activities across multiple data types — including clinical, real world, omics, manufacturing, and digital health data.
Identify and enable the use of tools, driving data quality automation and monitoring.
Design dashboards and reports to convey key metrics and communicate insights to scientists and leadership.
Collaborate with AI/ML, Global Functions, Real World Evidence, Clinical Data Management, Global Regulatory, J&J Technology, Epidemiology, and the Commercial organization to understand current quality controls and assess the value / need for subsequent controls.
Act as the liaison between R&D DSDH and J&J Technology, translating quality requirements into technical rules and data validation workflows.
Ensure data quality processes align (where applicable) to regulatory and industry standards, including FDA 21 CFR Part 11, GCP, GDPR, HIPAA, and ALCOA+ principles.
Support audit readiness by maintaining robust documentation and evidence of data quality processes.
Drive adoption of AI-assisted data quality tools and metadata-driven automation to reduce overhead.
Stay current on emerging data quality trends in the pharmaceutical and healthcare space.
Mentor junior quality analysts.
Requirements
8 – 10+ years of experience in pharma/biotech R&D or commercial functions, with significant exposure to data management or 6+ years of experience in pharma/biotech R&D or commercial functions with advanced degree.
Experience in master data management, ontology development, and/or knowledge graph application.
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