• Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans.
• Ensure the structure of all group activities is in alignment with corporate goals and initiatives.
• Coordinate global training activities to ensure compliance with regulatory requirements, ensuring that all team members are appropriately trained.
• Provide additional analysis of situations, reviewing various factors to solve problems, and proactively seek and implement improvements.
• Evaluate procedures and work instructions for process improvements, recommend changes to policies and procedures, and implement changes, as necessary.
• Act as subject matter expert for Training and participate in cGMP compliance inspections by the FDA, customers, and/or other regulatory bodies. This includes retrieval of quality documents/records/trend data and any other documentation requested during these inspections as well as defending Quality System processes.
• Own and drive any NCR’s and CAPA’s related to the Training System.
• Communicate and train internal customers when processes are changed.
• Responsible for providing Quality and MasterControl Orientation training.
• Resolve and respond to quality system training issues and questions from throughout the organization. Recommend, implement, and document solutions for systemic training related issues.
• Analyze regulatory, business, and customer requirements, as well as current industry best practices; propose and implement any required changes or improvements to the Training System.
• Design, develop and implement Training System curriculum in conjunction with functional leadership.
• Promote a safe, positive, and inclusive work environment.