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 Associate Director of Software Quality will ensure regulatory compliance of GRAIL’s software products and systems. As a subject matter expert in medical device software regulations and software development methodologies, the Associate Director will lead software design control efforts, enforce GxP and CSV principles, ensure software system audit readiness and support cross functional teams.

You will:

• Provide subject expertise and input in the following areas: quality standards for software applications and systems that the company develops in support of the commercial product; quality processes, assessments and validations of third-party tools used or in or for application development
• Lead Software Quality activities associated with GRAIL’s new and sustaining software product development with a focus on design control and regulatory compliance
• Responsible for Software Quality Engineering (QE) project deliverables, e.g., hazard analysis
• Collaborate with all departments to provide guidance on Software QA methodologies, requirements and tools
• Support internal, supplier and partner audits and regulatory inspections of quality management functions, processes, and procedures with regards to software
• Ensure FDA and ISO software guidelines and regulations are understood, applied and implemented across all software platforms
• Develop a software continuous improvement mindset, ensuring that software development issues are addressed and solutions are integrated back into the workflows and processes
• Partner with the Regulatory Affairs team to define software requirements for regulatory submissions
• Participate in advancing GRAIL’s regulatory footprint as a subject matter expert in design controls, risk management, and change control
• Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
• Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for acquiring results
• Develop positive relationships with key partners throughout GRAIL
• Enforce and execute standards and compliance with results-based key performance indicators, root cause analysis and defect prevention techniques, test standards and reports

Your background and qualifications will include:

• Bachelor’s degree in Computer Science or related field required.
• 8+ years of Quality Engineering experience in a regulated medical device manufacturing environment
• 5+ years software quality assurance management with proven success in delivering large and complex software projects supporting multiple engineering teams
• Ability to plan and lead Software Quality project activities
• Specialist in FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, 21 CFR Part 11 and Computer System Validation
• Industry experience within in-vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable
• Familiarity with project collaboration tools, e.g., Confluence, Jira
• An interest in learning new software platforms and technologies
• Proven SW Development Life Cycle (SDLC) background and experience, familiarity and direct experience with Agile development methodologies and Continuous Integration and Continuous Deployment (CI/CD)
• Knowledge of AI/ML technology and concepts
• Experience hiring, mentoring and coaching top software quality engineering talent
• Excellent interpersonal communication (written and verbal), with the ability to demonstrate technical concepts to non-technical audiences
• Acknowledge by others as proactive, engaging, and collaborative

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.

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.