Senior / Staff Data Integrity Engineer # 4942

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 Responsibilities: Support the implementation and execution of the GRAIL Data Integrity Program Act as Data Integrity Subject Matter Expert within the organization Perform quarterly Data Integrity reviews and generate quarterly reporting Identify Data Integrity risk and/or impact within following processes: CAPA, Non-conformances, Clinical Quality Events, Clinical Protocol Deviations and Change Control Activities Represent Data Integrity interests for supplier, internal and 3rd party Audits Able to build alignment with business partners within GRAIL including Clinical Development, Clinical Lab, Software/IT, Research, Manufacturing, Warehouse, Facilities, and Commercial Operations leaders Ability to demonstrate strategic thinking capability with a strong project management focus while balancing conflicting priorities Enhance relationships and networks with senior partners who are not familiar with the subject matter often requiring persuasion Adapt style to different audiences and advise others on difficult matters 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) Experience includes: 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 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: 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) Regulatory submission of medical devices (e.g. IVDD, IVDR, FDA 21 CFR, UK MDR 2002) Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56) Preferred Qualifications: Excellent communications skills Strong Documentation Skills You are analytical, can set priorities, have a sense of planning and can work independently Quality minded