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.

As part of the Quality organization, the Senior Quality Specialist, Training will be responsible for supporting the maintenance, delivery, and continuous improvement of GRAIL’s corporate training program by combining an ability to engage and educate with an understanding of GxP and quality processes. The Quality Specialist, Training will support learning management system (LMS) administration responsibilities, manage training content across multiple functional areas, and work directly with key collaborators to build and deploy standard training workflows. This position will report to the Quality Manager, Training and can be remote-based, as well as based out of any GRAIL location in the United States.

You will:

• Under mentorship of Quality leadership, support GRAIL’s corporate-wide training program, applying knowledge or quality system processes to enhance and improve training efficiency.
• Responsible for the administration of GRAIL’s electronic learning management system (eLMS), including modifying user groups/roles, training items, curricula, and assignments.
• Collaborate with functional subject matter experts (SMEs) to develop training content and curricula structure, based on training needs analysis.
• Provide subject expertise and input for quality system process improvements and system configurations to ensure that product and customer requirements are met.
• Review and revise training materials for current processes and applicable organizational, governmental, and/or regulatory changes.
• Manage generation of training reports and key performance indicators, metrics, and trends; assess metrics using GRAIL’s eLMS to identify training needs and improvement projects.
• Maintain training documentation for compliance and training curricula across the organization.
• Conduct or facilitate required and recommended training sessions.
• Support ongoing training project components, including meeting planning and facilitation, project plan execution, and communication.
• Assist with employee on-boarding training on general and quality-specific requirements.
• Develop a continuous improvement mentality, ensuring that training/eLMS issues are addressed and resolved and solutions are integrated back into existing workflows and processes.
• Participate in quality audits and regulatory inspections and collaborate with different departments to support internal audits.
• Contribute to the implementation and design of GRAIL’s corporate training program for cross-functional, localized, and other corporate training initiatives.
• Cultivate positive relationships with key collaborators and cross-functional partners throughout GRAIL, including third-party vendors/consultants.

Your qualifications and background will include:

• Bachelor’s degree in a scientific or related field preferred.
• 3+ years of training experience, including working with LMS/eLMS systems in a biotechnology, healthcare, academic, research, or other regulated environment.
• Knowledge of quality procedures, processes, and guidelines, and the ability to interpret and operationalize quality system regulations.
• Proven background in eLearning design and development; experience in training facilitation, curriculum/training plan development, and instructional design preferred.
• Experience or familiarity with the following: 21 CFR 820, ISO 13485, CAP/CLIA, and ICH/GCP with a focus on IVDR or MDR preferred.
• Clear ability to work well under pressure with a proactive approach, including managing multiple priorities, deliverables, and deadlines.
• Strong analytical skills and a passion for solving problems via collaboration and a growth mindset.
• Strong and effective written and oral communication skills across all levels of the organization, with a diverse group of individuals.
• Ability and passion to provide excellent internal and external customer service.
• Team-oriented approach with proven ability to quickly and consistently establish rapport and collaborate effectively with key collaborators, cross-functional partners, and leadership.
• Excellent organization and time management skills.
• Proficiency with standard office software applications including Google Suite and Zoom; prior electronic document management system (eDMS) and experience using Veeva Vault preferred.

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.