GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

The Senior Software Quality Engineer - CSV/CSA is the subject matter expert in Computer System Validation (CSV) and Computer Software Assurance (CSA). As a SME, the Senior Software Quality Engineer will work closely with cross-functional teams to provide software quality guidance for successful implementation of computerized systems and equipment software programs within a regulated environment. This role will be based at GRAIL’s RTP facility in Durham, NC.

You will:

• Oversee and perform computer system validation (CSV) and computer software assurance (CSA) activities and ensure the approach and execution aligns to applicable standards/regulations and GRAIL’s directives and procedures.
• Provide software guidance to teams across GRAIL through assessment, implementation and maintenance of third-party software including Excel spreadsheets, equipment software embedded in or associated with an equipment, configurable software methods, OTS/SOUP, SaaS applications through 21 CFR Part 11 and GxP software requirements.
• Advise and support cross-functional project teams to provide software quality expertise and facilitate the successful execution of software testing. Implementation of qualification/validation requirements for new and existing computer systems.
• Provide input into SOPs, templates, work instructions and relevant documents to support software projects, production equipment software and GRAIL’s QMS. Support validation activities not limited to review of plans, protocols and reports.
• Support the implementation and adoption of the global CSV programs, data integrity implementation and strategic plans for systems within the CSV program.
• Work closely with Business/Functional owner(s) in the analysis of requirements and specifications.
• Provide support of QMS teams such as Corrective and Preventive Actions (CAPA), supplier corrective actions, and document control as assigned.
• Provide technical guidance and training as needed.
• Participate in audits and continuous improvement efforts related to CSV programs.

• A minimum of BA/BS with 5 years of Computer System Validation experience in a regulated medical device manufacturing environment.
• Knowledge of, and experience with medical device software development life cycles (SDLC) and Design Control processes.
• Knowledge of FDA 21 CFR 820, ISO 13485, ISO 15189, ISO 14971 and IEC 62304 and demonstrated application within a production environment.
• Knowledge of GAMP 5 and the application in a production environment.
• Understanding of 21CFR Part 11 and CSV documentation, compliance and maintenance.
• Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable.
• Computer competency in MS Office, G Suite, and Veeva Quality Vault, Jira and Confluence preferred. An aptitude for learning new software platforms and technologies.
• Ability to handle challenging issues and exercise judgment, based on experience, with minimal guidance from a manager.
• Acknowledged by others as proactive, engaging, and collaborative.

Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.

In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.