The primary goal of this function is to develop structure/systems and materials to enhance the learning and education of training performed and documented in the Global Compliance Training system. The position is responsible for maintaining the effectiveness of the quality systems for Learning and Education, which will result in improved patient safety while at the same time stand up to regulatory scrutiny. The position manages projects related to key subject matter training needs of the global organization and collaborates with subject matter experts and site personnel. The position supports implementation, training and monitoring of projects and programs to ensure cGMP requirements are continuously being met. Additional responsibilities may include coordination of training initiatives and documentation with new product teams plus successful completion of assigned and self initiated training projects. This role will be the key driver in demonstrating to the FDA and other regulatory bodies that Hospira fully understands the importance and intent of Learning and Education, and has taken the necessary steps to ensure that understanding is fully integrated throughout the entire organization.
Implement and maintain the effectiveness of the quality system.
Identify and provide compliance training as needed in support of global sites.
Deliver both standard and custom training classes.
Recognize and resolve compliance issues through reports, documenting and training functions.
Responsible for assuring through audits that systems are established, maintained and followed at the site to meet local and global requirements as well as applicable regulations.
Review and recommend additional compliance needs.
Attend compliance meetings, facilitate quality initiatives, and become familiar with compliance and quality documentation.
Coordinate input from multiple areas.
Develops project goals into project tasks and aligns projects with QA Strategies and reviews projects for Corporate, Site and Region training impact.
Recognizes and removes barriers to project completion.
Regularly requires use of ingenuity and creative thinking.
Anticipates, recognizes, communicates and manages quality issues with appropriate organization/site and recommends and approves actions to resolve issues.
Establishes and sponsors broad training process improvement initiatives.
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For this position it is essential that the candidate have a Bachelor’s degree in a related discipline such as Business, Communications, Education, or Workforce Development. Master’s degree preferred. This level of education will allow this person to develop Learning and Education needs of the Compliance Training System for Hospira which will result in:
Establishing education materials for core curricula/critical tasks of pharmaceutical and device positions in the organization.
Developing learning and education materials that are effective in establishing employee understanding.
Effective Learning and Education/Training will translate into improved patient safety.
Minimum experience 5-7 years in a training and development role and/or training in a regulated environment, experience designing learning interventions to meet business objectives desired. Training Program Manager 3-4 years experience. Instructional Design Project Management and knowledge of Software validation desired. Must be able to multi-task and work in a fast paced environment. Strong computer skills and knowledge of systems are a must. Must have excellent written and verbal communication skills.
Hospira - 19 months ago
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Hospira helps hospitals heal the hurting. The company makes specialty injectable pharmaceuticals (primarily generics) including...