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GRAIL is a healthcare company pioneering early cancer detection using next-generation sequencing, population-scale clinical studies, and advanced data science. The company is headquartered in the Bay Area with additional locations in Washington D.C., North Carolina, and the United Kingdom.
This Senior Data Integrity Engineer role is a subject matter expert position supporting GRAIL's Data Integrity Program. You will serve as the organizational authority on data integrity matters, performing quarterly reviews and generating comprehensive reporting. Key responsibilities include identifying data integrity risks and impacts across critical processes including CAPA, non-conformances, clinical quality events, protocol deviations, and change control activities. You will represent data integrity interests during supplier, internal, and third-party audits.
The role requires strong cross-functional collaboration with Clinical Development, Clinical Lab, Software/IT, Research, Manufacturing, Warehouse, Facilities, and Commercial Operations leaders. You will demonstrate strategic thinking with a project management focus while balancing competing priorities. This position involves building relationships with senior partners unfamiliar with data integrity, adapting communication style to different audiences, and advising on complex matters.
The ideal candidate combines technical depth with regulatory expertise. You will act as a bridge between technical teams and quality/compliance functions, ensuring data integrity principles are embedded across systems and processes. Success requires the ability to influence without direct authority, translate technical concepts for non-technical stakeholders, and maintain focus on regulatory compliance and organizational risk mitigation.
REQUIREMENTS:
- BS/BA degree with 5+ years of related experience, OR Master's degree with 3+ years of related experience (preferred: Life Science, Engineering, or Computer/Tech degree)
- Strong background in either GxP Computer System Validation OR technical background (IT, Software Development, Clinical Data Management, Data Sciences) with proven hands-on GxP environment and data integrity experience
- Data integrity/ALCOA+/Data Sciences experience in 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
- Demonstrated knowledge of applicable regulatory standards including: GMP quality management systems (ISO 13485), Risk assessment frameworks (ISO 14971), Clinical laboratory regulations (CAP, CLIA, NYSDOH, ISO 15189), Protected health information (HIPAA, GDPR), Regulatory submission of medical devices (IVDD, IVDR, FDA 21 CFR, UK MDR 2002), Development and Operations in regulated clinical study environments (ICH E6 GCP, ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)
PREFERRED QUALIFICATIONS:
- Excellent communication skills
- Strong documentation skills
- Analytical mindset with ability to set priorities, plan, and work independently
- Quality-minded orientation
