Essential Functions:

• Ensure that the training compliance requirements are fulfilled and documented according to the applicable standards and regulations.
• Work with departmental representatives to manage a role-based quality training program for new hires, existing employees, and contractors.
• Assess the training needs and gaps of the organization and provide recommendations for improvement.
• Manage Training Requirements, Curricula, Learner Roles, and Person records in the Veeva Vault Training LMS.
• Monitor and evaluate the effectiveness and impact of the quality training program and provide feedback and reports including reporting on training compliance metrics and indicators.
• Coordinate and collaborate with management to align the quality training programs with the organizational goals and objectives.
• SME for Training during audits or inspections.
• Stay updated on the latest trends and best practices in quality training and development.

Requirements:

• Bachelor’s BA/BS degree or equivalent experience.
• At least 5 years of experience in quality training, quality assurance, or quality management.
• Experience with Veeva Vault Training or similar LMS platforms.
• Strong knowledge and skills in GxP quality standards, methodologies, and tools.
• Understanding of current regulatory expectations including 21CFR Part 11 requirements.
• Excellent communication, presentation, and facilitation skills.
• Ability to analyze and evaluate the quality training needs and outcomes.
• Ability to work independently and collaboratively with cross-functional teams.
• Proficient in Microsoft Office and SmartSheet.
• Ability to meet deadlines and multi-task efficiently.
• Strong attention to detail, organizational skills, ability to work in a faced paced environment.