Quality Systems Training Manager # 4732

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.

• 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.

• 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.

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)