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GRAIL

Senior, Staff Data Integrity Engineer

GRAIL

. Support the implementation and execution of the GRAIL Data Integrity Program .

Posted 9/30/2026full-timeSunnyvale • California • United StatesSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in Data Integrity principles and GxP Computer System Validation, ensuring compliance with regulatory standards while effectively managing risks and impacts related to data integrity. Proven ability to collaborate across various departments and communicate complex issues to diverse audiences.

Highest-signal resume keywords
Data Integrity Subject Matter ExpertGxP Computer System ValidationRisk Assessment ExperienceRegulatory Compliance KnowledgeExcellent Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Data Integrity PrinciplesGxP Environment ExperienceComputer System ValidationRisk Assessment FrameworksData Sciences ExperienceALCOA+ KnowledgeRegulatory Standards KnowledgeClinical Quality Events ManagementChange Control ActivitiesQuarterly Reporting
Soft Skills
Analytical AbilitiesPrioritization SkillsPlanning SkillsIndependent WorkingStrong Documentation Skills
Industry Keywords
GMP Quality Management SystemsISO 13485ISO 14971CAP RegulationsCLIA RegulationsHIPAAGDPRIVDDIVDRICH E6/GCP

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • Support the implementation and execution of the GRAIL Data Integrity Program
  • Act as a Data Integrity Subject Matter Expert throughout the organization and across the data life cycle
  • Prepare and help implement Data Integrity requirements correctly
  • Apply Data Integrity principles
  • Perform quarterly Data Integrity reviews and generate quarterly reporting
  • Perform risk assessments and identify Data Integrity impact and risks within CAPA, non-conformances, Clinical Quality Events, Clinical Protocol Deviations, and Change Control Activities
  • Represent Data Integrity interests in supplier, internal, and third-party audits
  • Build alignment with business partners across Clinical Development, Clinical Lab, Software/IT, Research, Manufacturing, Warehouse, Facilities, and Commercial Operations
  • Demonstrate strategic thinking and project management while balancing conflicting priorities
  • Develop relationships with senior partners and advise different audiences on difficult matters
  • Assure regulatory compliance, product quality, and patient safety related to data integrity; detect, investigate, and correct data integrity issues

Requirements

What you’ll need
  • Strong background in GxP Computer System Validation or a technical background (IT, SW Development, Clinical Data Management, Data Sciences, etc.) with proven hands-on work experience in a GxP environment and data integrity in a GxP context
  • BS/BA degree and 5+ years of related experience, or Master's degree and 3+ years of related experience; preferably in Life Science, Engineering, or Computer/Technology
  • Data integrity/ALCOA+/Data Sciences experience in a human pharmaceutical or medical device company
  • Good understanding of risk and impact assessments
  • Experience working in a GxP environment
  • Computer System Validation experience, including sound knowledge of 21 CFR Part 11
  • Knowledge of applicable regulatory standards, including GMP quality management systems (e.g. ISO 13485), risk assessment frameworks (e.g. ISO 14971), clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189), protected health information (e.g. HIPAA, GDPR), medical-device regulatory submissions (e.g. IVDD, IVDR, FDA 21 CFR, UK MDR 2002), and regulated clinical study development and operations (e.g. ICH E6/GCP, ISO 20916, FDA 21 CFR Parts 11, 50, 54, and 56)
  • Excellent communication skills
  • Strong documentation skills
  • Analytical, prioritization, planning, and independent-working abilities
  • Quality-minded

Benefits

Comp & perks
  • Annual bonus and/or other incentives
  • Flexible time off or vacation
  • 401(k) retirement plan with employer match
  • Medical, dental, and vision coverage
  • Well-being programs
  • Reasonable accommodations for qualified individuals with disabilities