Director of Training, Operations

Job Description

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