Job Description

Program Timeline & Location

This is a one-year contract position that will conclude twelve months from the candidates official start date. This role will be 5 days on-site in Columbus, OH.

The Importance of the Role

This individual will be a member of the QA Compliance team supporting research & development training needs, primarily focused on preclinical and clinical genetic therapies research functions. This individual will be responsible for adhering to corporate GxP Training Policy and procedures and will perform various training responsibilities to ensure ongoing compliance. This position will reside on-site in Columbus, OH and will perform corporate training tasks work closely with Testing Facility Management (TFM) and site management to ensure sustained compliance. This position involves a variety of training management responsibilities, including the oversight and support of improvement initiatives, which includes revamping R&D training roles and curricula; administration of the training management system and process improvements; and ensuring training completion is performed on-time documented, completed, and archived in a compliant manner.

The Opportunity to Make a Difference

• Ensure compliance with corporate policies and procedures.
• Support onboarding and offboarding of personnel, including establishing training requisites with hiring manager.
• Assess training needs across R&D functional areas, working in collaboration with QA Compliance, Testing Facility Management (TFM), and site leadership to ensure training is fit for purpose in accordance with each learner’s job description and scope of responsibility.
• Maintain GxP Training Learning Management System (LMS) (Veeva Training Vault & Learn GxP content) for continued compliance, which includes maintaining learner roles, curricula, training requirements and training assignments.
• Partner with training management to revamp training roles and curricula based on QA Corporate and local R&D business needs, ensuring processes & naming conventions are scalable and sustainable for future growth.
• Provide daily support to personnel to meet business goals and priorities, including the review of all new/revised documentation being processed that impact GTCOE operations.
• Design and control custom training materials (eLearning SCORM courses & microlearning videos), as assigned. Work with functional SMEs to ensure content is complete, accurate, and designed properly to ensure effective adult learning.
• Conduct annual curricula reviews with GTCOE functional management and ensure employee/contractor job descriptions & CV documentation is up to date and inspection ready.
• Drive on-time training completion across GTCOE functional teams to meet KPI targets.
• Update / maintain training procedures, templates, forms, and records, as assigned.
• Provide training support during audits/regulatory inspections, as assigned.

More About You

• B.S. degree preferred, preferably in Biology, Molecular Biology, Chemistry, or related education/business field.
• A minimum of 8 years of experience of comparable training management experience working within the pharmaceutical/biotech industry required; vast R&D and GLP (21 CFR Part 58) training knowledge is a plus.
• Experience administering an electronic training learning management system (LMS) is a must, experience using Veeva Training Vault is preferred.
• Strong team player with demonstrated track record of success in a cross-functional team and fast-moving environment.
• Excellent organizational and oral/written communication skills required.
• Ability to multi-task and adapt quickly to changing business needs.

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