Senior Data Integrity Engineer — GxP & ALCOA+ Champion

GRAIL; Sunnyvale (CA); On-site; USD 135,000 - 180,000; Full time

Benefits offered by this job

Flexible time off

401(k) match

Medical, dental, vision

Job summary

GRAIL seeks a Senior / Staff Data Integrity Engineer to ensure ALCOA+ data integrity in the data life cycle under the Data Integrity Office. You will act as a subject matter expert, perform risk assessments, and implement Data Integrity requirements to support regulatory compliance, product quality, and patient safety.

This cross-functional role requires collaboration across Clinical Development, Software/IT, and Manufacturing, with a focus on audits, CAPA, and change control activities to

Qualifications

• Experience in a GxP environment with data integrity.
• Knowledge of risk and impact assessments in regulated settings.
• Familiarity with GMP/Quality systems and regulatory standards.

Responsibilities

• Support implementation and execution of the GRAIL Data Integrity Program.
• Act as Data Integrity SME within the organization; lead reviews and reporting.
• Identify data integrity risk within CAPA, non-conformances, clinical quality events, and change control.
• Represent Data Integrity interests for supplier, internal and 3rd party audits.
• Collaborate with Clinical Development, Clinical Lab, Software/IT, Research, Manufacturing, and other partners.
• Demonstrate strategic thinking with strong project management and balancing priorities.

Skills

GxP Validation

Data Integrity

Regulatory Compliance

Risk Assessment

21 CFR Part 11

Education

BS/BA + 5+ yrs

Masters + 3+ yrs

Tools

CAPA systems

Job description

GRAIL seeks a Senior / Staff Data Integrity Engineer to ensure ALCOA+ data integrity in the data life cycle under the Data Integrity Office. You will act as a subject matter expert, perform risk assessments, and implement Data Integrity requirements to support regulatory compliance, product quality, and patient safety.

This cross-functional role requires collaboration across Clinical Development, Software/IT, and Manufacturing, with a focus on audits, CAPA, and change control activities to