talent groupsEast Boston, MA
Senior Specialist, R&D Training
Senior Specialist, R&D Training
Senior Specialist, R&D Training
talent groupsEast Boston, MA
yesterday
Professional and Management Development TrainingResearch and Development in BiotechnologyPharmaceutical Preparation Manufacturing
Apply for this role (opens in a new tab)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 LI-Remote
Also on the board Same function, level within a rung
Level
Lead
Location
East Boston, MA
Occupation
Training and Development Specialists
Industry
Professional and Management Development Training
Posted
yesterday