Quality Systems Training Manager # 4732 at Grailbio

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 GRAIL is seeking a highly motivated and detail-oriented Quality Systems Training Manager to support the execution, administration, and continuous improvement of the Quality Systems Training Program within Veeva’s Learning Management System (LMS). This role is responsible for managing key operational aspects of training within the Quality Management System (QMS), with a strong focus on quality training compliance, Veeva Vault LMS administration and configuration, and inspection readiness. The Quality Systems Training Manager partners cross-functionally with Quality, Document Control, Clinical Laboratory Operations, functional leaders, document authors, and other stakeholders to ensure training requirements are effectively implemented, maintained, monitored, and documented in accordance with applicable regulatory, accreditation, and business requirements. This role supports training program effectiveness through strong system oversight, compliant training administration, metrics and reporting, audit support, and continuous improvement initiatives.    This role is based at our Durham, North Carolina, office. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site. Responsibilities: Quality Systems Training Program Execution • Support the execution and continuous improvement of the Quality Systems Training Program in alignment with GRAIL’s QMS, regulatory requirements, and internal compliance expectations. • Partner with Quality leadership and cross-functional stakeholders to implement quality training strategies that support business initiatives, role readiness, and organizational effectiveness. • Ensure training processes are administered in a compliant, consistent, and inspection-ready manner across applicable functions. • Support standardization of training practices, governance, and documentation to promote effectiveness, scalability, and consistency across the organization. Veeva Vault LMS Administration and Configuration • Administer and maintain training objects within Veeva Vault LMS, including learner roles, curricula, training assignments, notifications, dashboards, reports, and related system configuration elements. • Support ongoing LMS configuration and optimization to ensure role-based training assignments, curricula structures, training-dependent access, and reporting capabilities remain accurate and aligned to business needs. • Partner with IT and applicable business owners to support training-related onboarding and access workflows, as required. • Partner with Document Control, document authors, training leads, functional leads, and process owners to translate document changes and procedural updates into appropriate training assignments and curricula updates. • Support administration of training forms, records, and associated documentation in accordance with Good Documentation Practices (GDP) and document control requirements. • Help ensure training metadata, assignment logic, and LMS structures are configured appropriately to support compliant training issuance and completion tracking. • Contribute to special projects and broader program enhancements related to quality systems training, LMS process improvements, lab training functionality, and inspection readiness initiatives. • Support training effectiveness activities by evaluating metrics, learner feedback, competency outcomes, deviations, CAPAs, and audit observations related to training systems and processes. • May participate in internal audits, external inspections, and other readiness activities by preparing training-related documentation, reports, evidence, and responses to requests. • Support Veeva LMS administration and coordination of clinical lab training and on-the-job training (OJT) processes in collaboration with laboratory leadership, functional leads, and qualified trainers. • Partner with clinical lab stakeholders to help ensure training documentation, training records, and competency-related records are maintained and organized in accordance with applicable procedures and retention requirements. Required Qualifications: • Bachelor’s degree in Life Sciences, Education, Quality, Regulatory, Clinical Laboratory Science, or a related discipline. • Experience working in a regulated environment governed by one or more of the following: GxP, ISO 13485, ISO 15189, 21 CFR Part 820, 21 CFR Part 493 (CLIA), CAP, and 21 CFR Part 11. • Progressive experience in training, quality systems, learning management systems, or regulated operations within the life sciences, medical device, biotech, diagnostics, or clinical laboratory environment. • Experience administering or supporting a Learning Management System (LMS) in a regulated environment. • Experience supporting or managing training processes tied to quality systems, controlled documents, and role-based training requirements. • Strong analytical, organizational, and project management skills, with the ability to manage multiple priorities and stakeholders simultaneously. • Strong written and verbal communication skills, including the ability to facilitate training, communicate requirements clearly, and partner effectively across functions. • Inspection readiness mindset and experience supporting training-related compliance activities. Preferred Qualifications: • Experience with Veeva Vault Training / Veeva Vault QMS, including curricula, learner roles, training assignments, reporting, and configuration support. • Experience supporting clinical laboratory training, on-the-job training documentation, or competency-related training processes. • Experience supporting audit responses, regulatory inspections, CAPAs, deviations, and training remediation activities. • Familiarity with document control, quality records management, and Good Documentation Practices for both electronic and paper records. • Experience developing or revising training materials, technical documentation, SOP-associated training content, and job aids. • Experience with reporting and trend analysis to support training compliance and management review. • New York State Department of Health experience or familiarity is preferred, but not required. • Working knowledge of regulated training program administration within a QMS, particularly Veeva LMS. • Strong understanding of role-based training assignment logic, curricula management, and LMS workflow administration. • Ability to interpret training needs and convert them into actionable system, process, or documentation updates. • Ability to assess training data and metrics to identify compliance risks, gaps, and improvement opportunities. • Ability to work both strategically and tactically, balancing day-to-day administration with broader process improvement efforts. • Ability to manage sensitive, controlled, and compliance-related documentation with accuracy and attention to detail. • Ability to support internal clients with a high level of responsiveness, professionalism, and service orientation. Regulatory and Compliance Environment: This role operates in a regulated environment and is expected to support training processes in accordance with applicable internal procedures and external requirements, which may include: • GxP requirements • ISO 13485 • ISO 15189 • 21 CFR Part 820 • 21 CFR Part 493 (CLIA) • CAP requirements • 21 CFR Part 11 • Good Documentation Practices (GDP) The expected, full-time, annual base pay scale for this position is $118K - $156K  for Durham, NC.  Actual base pay will consider skills, experience, and location. This role may be eligible for other forms of compensation, including an annual bonus and/or incentives, subject to the terms of the applicable plans and Company discretion. This range reflects a good-faith estimate of the range that the Company reasonably expects to pay for the position upon hire; the actual compensation offered may vary depending on factors such as the candidate’s qualifications. Employees in this role are also eligible for GRAIL’s comprehensive and competitive benefits package, offered in accordance with our applicable plans and policies. This package currently includes flexible time-off or vacation; a 401(k) retirement plan with employer match; medical, dental, and vision coverage; and carefully selected mindfulness programs. GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, , or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at [Upgrade to PRO to see contact] if you require an accommodation to apply for an open position. GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!