Senior L&D Specialist, Global QMS Training- Remote

Job Description

The Sr. L&D Specialist, Global QMS Training will serve as a senior individual contributor within Quality. 

This individual will support the management of the global training process, lead strategic training projects, and collaborate with global process owners and cross-functional teams to develop and implement key learning strategies and programs in support of Global QMS strategies and goals. 

Job Duties

• Support the management of the global training process, including global documentation, strategy, compliance, administration on the LMS, and audit needs.
• Consult with process owners on the end-to-end strategy (needs assessment, design, development, implementation, and effectiveness) for training or other solutions for global QMS training programs across Olympus.
• Provide support with the development and use of reports in support of audits, manager accountability, and business partner requirements.
• Work with vendors to provide quality cost-effective solutions as needed. 
• Collaborate with Subject Matter Experts on the current learning needs and strategies, as well as anticipating future training needs based on business requirements and opportunities for improvement.
• Organize and implement the delivery of learning solutions including the sustained forecasting and delivery of programs to meet business needs. 
• Partner with the learning administration team to manage assignments, including data analysis.
• Participate in project teams to improve overall compliance performance to established metrics and requirements.
• Monitor and evaluate training program’s effectiveness.
• Utilize cost-effective, consistent, and best-practice training methods and ensures compliance with both regulatory and internal compliance.
• Provide support on quality and compliance projects as requested, and perform other assigned duties, as needed.
• Partners with teams on the communication and change management activities for training implementations.

Job Requirements

Required:

• A minimum of a 4-year college degree (Bachelor’s Degree) or equivalent related work experience is required
• A minimum of 5 years of professional experience in the medical device or pharmaceutical industry is required.
• Minimum of 5 years of developing and implementing training program experience in a medical device or pharmaceutical environment, preferably to global users. 
• Minimum of 5 years’ experience with utilizing a Learning Management System.
• Working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, SOR 98-282 CMDR (Canada), J-PAL (Japanese), European Medical Devices Directives, European Medical Devices Regulations, ANVISA 16/2013 (Brazil), TG(MD)R Sch3 (Australia), and any other regulations or standards applicable to the site is required.
• Strong project management skills; strong computer skills and use of software applications such as MS Windows, MS Office (Word, Excel, PowerPoint); strong written and oral communication skills, are required
• Knowledge and understanding of regulatory and technical training requirements and associated processes.
• Proven experience in the delivery of training with excellent presentation public speaking and facilitation skills.
• Thorough knowledge of adult learning training and applying development principles and techniques for success.
• Knowledge of the application of Learning Management Systems or tools.
• Approximately 20% travel, including globally.
• Availability to take evening and early morning teleconferences.

Preferred:

• Experience supporting the learning and development need of an Operations environment preferred.
• Project management experience strongly preferred particularly in the design implementation and sustainment of learning and performance initiatives/processes.
• Knowledge and experience with current and emerging Learning Technologies preferred.
• Knowledge and experience developing and implementing training programs using current and emerging training authoring tools preferred (e.g., Articulate 360, Brainshark)
• Experience in working within or with Japanese companies is desirable.