Director of Training, Operations


Houston, TX


Duties And Responsibilities

  • Develops and implements a comprehensive training strategy, incorporating Good Manufacturing Practices (GMP) and FDA regulations, to enhance the knowledge and skills of employees across all operations departments
  • Maintains a thorough understanding of current and emerging FDA regulations, industry trends, and best practices in pharmaceutical manufacturing
  • Collaborates with various departments to identify specific training needs and tailors programs as needed to address and improve knowledge gaps
  • Designs and implements a system for tracking and documenting employee training progress, compliance, and outcomes
  • Delivers and oversees delivery of training sessions, which may involve hiring and managing additional trainers or educators
  • Works closely with the Quality Assurance (QA) team to ensure training activities align with quality and compliance objectives
  • Develops and maintains training materials and resources that are accurate, comprehensive, and engaging
  • Ensures that all training programs meet FDA requirements and other applicable regulations
  • Provides dotted line supervision and guidance to the operations training team
  • Performs other duties as assigned

Knowledge And Skills

  • In-depth understanding of FDA regulations and guidelines related to pharmaceutical manufacturing
  • Excellent communication skills, both verbal and written
  • Strong leadership skills with the ability to inspire and motivate a team
  • Exceptional organizational and project management skills
  • Proficiency in various training software and technology
  • Strong interpersonal skills with the ability to collaborate and build relationships at all levels of the organization

Experience And Qualifications

  • Bachelor’s degree in pharmaceutical science, life science, instructional design, or a related field.
  • Advanced degree preferred
  • Minimum of 5 years of experience in a GMP-regulated pharmaceutical environment, with at least 2 years in learning and development
  • 5 years’ experience performing work that requires decision making and the consistent exercise of independent judgment and discretion
  • 2 years of experience with a Learning Management System
  • Manufacturing and/or Quality experience preferred
  • Proven experience in developing and implementing training strategies and programs
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