Quality Systems Training Manager # 4732

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)    

What We Do

GRAIL is a healthcare company whose mission is to detect cancer early when it can be cured. GRAIL is using the power of high-intensity 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 and commercialize pioneering products.

Why Work With Us

Everything we do is guided by our mission to detect cancer early when it can be cured. It’s the reason we’re here and it’s no small task. The right people make all the difference. That’s why we’re looking for those who strive to share their knowledge contribute their skills inspire each other and commit to something bigger than themselves.

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