GMP Training Manager

Roles & Responsibilities

• Conduct training needs analysis to identify knowledge and procedural gaps within the manufacturing process
• Create and oversee on-the-job training criteria through the development of train-the-trainer programs
• Routinely deliver various cGMP training sessions for new and existing employees, focusing on specific SOPs, equipment, change controls, documentation, and health and safety-related topics
• Manage and maintain training content and records following internal and external regulations
• In conjunction with HR and EHS, ensure the effectiveness of new hire onboarding activities
• Implement a formalized skill matrix to promote growth and development
• Issues reports on the status of training initiatives
• Track new hire training progress and ensure completion
• Evaluate the effectiveness of all training initiatives and implement changes as necessary to ensure quality and safety guidelines are included appropriately within training content
• Ensure quality and safety guidelines are included appropriately within training content
• Provide support in regulatory and customer audits related to training documentation
• Contribute to the development and reviewing of SOPs, Technical Manuals, and safety procedures

Qualification

• To perform this Job successfully, an individual must be able to perform each essential duty satisfactorily.
• Education And/ Or Experience: Bachelor's degree in a scientific discipline, or equivalent 5+ years GMP training experience in the pharmaceutical industry 5-7 years experience in a biotech/pharmaceutical, GMP, or FDA regulated environment, preferably in a training or leadership capacity
• Experience: Experience in training to those who may not be familiar with cGMP concepts Experience with the preparation and delivery of training materials
• Knowledge, Skills, And Abilities: Bilingual preferred Ability to ensure full training and safety compliance Ability to manage multiple priorities in a fast-paced environment Ability to analyze gaps and implement corrective actions Ability to collaborate cross-functionally and influence operational leaders Knowledge of adult learning principles and training delivery best practices Knowledge of safety, compliance, and contractual reporting requirements Familiarity with operational workflows in shift-based environments Experience with training tracking, documentation control, and audit readiness Strong written communication and reporting skills Ability to maintain organization and time management with strict deadline adherence Experience with problem-solving and escalation management Supervisory Responsibilities: Carries out management responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, planning, assigning, and directing work; performance evaluations; rewarding and disciplining employees; addressing complaints and resolving problems. Ensure employees are properly trained on tasks and safety requirements.