Hybrid Principal Scientist, Data Science – Data Quality

Posted 3 hours ago

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About the role

  • 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.
  • Understanding controlled vocabularies (e.g., SNOMED CT, MedDRA, LOINC).
  • Experience in data profiling and validation, including the use of tools and writing in SQL, Python and/or R.
  • Experience integrating data across discovery, development, clinical, regulatory, and/or commercial domains.
  • Strong understanding of data standardization and harmonization.
  • Experience working with / in validated environments.
  • Knowledge of FDA and EMA guidelines, especially around GxP, ALCOA+ data integrity principles, and 21 CFR Part 11 compliance.
  • Awareness of CDISC, SDTM, ADaM, HDF5 and H5mu standards.
  • Strong writing skills for creating / drafting of quality reports, SOPs and general guidelines.

Benefits

  • Health insurance
  • 401(k) matching
  • Paid time off
  • Flexible work arrangements
  • Professional development opportunities

Job title

Principal Scientist, Data Science – Data Quality

Job type

Experience level

Lead

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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