Senior / Staff Data Integrity Engineer # 4942
About The Position
GRAIL is a healthcare company pioneering new technologies to advance early cancer detection. 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 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. As a Senior / Staff Data Integrity Engineer, you will ensure that GRAIL data within scope of the Data Integrity Policy meets the ALCOA+ attributes. As part of the Data Integrity Office, you will function as a Subject Matter Expert (SME) on Data Integrity topics throughout the data life cycle. You will 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, ensuring data integrity and that detects, investigates, and corrects where needed.
Requirements
- 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)
Nice To Haves
- Excellent communications skills
- Strong Documentation Skills
- You are analytical, can set priorities, have a sense of planning and can work independently
- Quality minded
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
Benefits
- flexible time off or vacation
- a 401(k) retirement plan with employer match
- medical, dental, and vision coverage
- thoughtfully selected well-being programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
