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GRAIL
Sunnyvale, CA
Source: GRAIL careers · View original posting
From GRAIL's posting. “We” and “our” refer to the employer.
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
GRAIL is headquartered in the Bay Area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.
For more information, please visit grail.com
As a Senior / Staff Data Integrity Engineer you ensure that GRAIL data within scope of the Data Integrity Policy meets the ALCOA+ attributes. As part of the Data Integrity Office you function as Subject Matter Expert (SME) on Data Integrity topics throughout the data life cycle.
You prepare and help with the correct implementation of Data Integrity Requirements, apply Data Integrity principles, perform risk assessments and provide SME support for the correct identification of Data Integrity Impact and Data Integrity Risks within QMS processes. This is a cross functional role that assures regulatory compliance, product quality and patient safety related to data integrity that ensures data integrity and that detects, investigates and corrects where needed.
Able to build alignment with business partners within GRAIL including Clinical Development, Clinical Lab, Software/IT, Research, Manufacturing, Warehouse, Facilities, and Commercial Operations leaders
Required Qualifications:: The right candidate for this position has a strong background in either GxP Computer system validation or a technical background (IT, SW Development,Clinical Data Management, Data Sciences....) with proven hands on work experience in a GxP environment and data integrity in a GxP context..
BS/BA degree & 5+ years of related experience or Masters & 3+ years of related experience (pref Life Science, Engineering or Computer/Tech degree)
Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:
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