Duration: 9 months to start
Job Summary
This role supports an organization-wide initiative to assess, simplify, and right-size a biotechnology company's GxP training matrices — the curricula, learner roles, requisites, and individual training assignments that keep the organization audit-ready. You'll evaluate the current-state training architecture inside a Veeva Training LMS, identify redundancy and over- or under-assignment, and build a simplified, role-based structure in its place, all while keeping GxP training compliance fully intact throughout the project.
Responsibilities
- Ensure GxP training compliance is maintained throughout, with no lapses in required training or documented evidence of completion
- Assess current-state GxP training matrices across functional areas, mapping curricula to learner roles, requisites, and assigned personnel to find redundancies, gaps, and inconsistencies
- Develop and execute a simplification strategy for curricula and learner-role structures, scaling assignments to each role's actual scope
- Partner with functional area management, Quality Assurance, and process owners to define role-based training requirements and gain approval for changes
- Establish governance criteria for assigning requisites to learner roles to prevent over-training and support long-term matrix maintenance
- Configure, update, and maintain curricula, learner roles, requisites, and assignments within the Veeva Training LMS, including data cleanup
- Manage matrix changes through change control, and author or revise training procedures and governance documentation as needed
- Define and report metrics on project progress, training burden reduction, and compliance status to stakeholders
Qualifications
- Bachelor's degree in a scientific, technical, education, or related discipline, or an equivalent combination of education and experience
- Minimum 8 years of GxP training experience in the pharmaceutical, biotechnology, or medical device industry, including at least 3 years at a managerial level
- Working knowledge of a Veeva Training LMS (Veeva Vault Training), including curricula, learner role, and requisite configuration
- Demonstrated experience assessing, rationalizing, or simplifying training matrices or curricula architecture in a regulated environment
- Strong knowledge of GxP regulations and training compliance expectations, including data integrity principles
- Strong analytical skills, including the ability to work with large training assignment data sets (Excel, LMS reporting) to drive decisions
- Proven ability to work independently on a multi-year project scope with minimal supervision
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