Job Description

The Senior Manager, Global QMS Training will serve as a manager within QARA having responsibility to lead learning and development dedicated for all personnel who work within the global quality management system (QMS). Responsibilities include the development, delivery, implementation, evaluation, and administration of global QMS training that builds the Olympus capability in alignment with the business goals and skills.

Job Duties

• Manage the global training process, including global documentation, strategy, compliance, administration of the LMS, and audit needs.
• Lead the end-to-end strategy (needs assessment, design, development, implementation, and effectiveness) for training or other solutions for global QMS training programs across Olympus.
• Manage and supervise employees developing, monitoring, and implementing Global QMS training requirements and managing the global learning management system.
• Lead, manage, and support the development and use of reports in support of audits, manager accountability, and business partner requirements.
• Leads as needed and/or supports negotiations and project management of resources, schedules, contracts and fees for externally developed programs or training updates. 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 and any re-training actions necessary.
• Create and manage assignments, including data analysis.
• Serve on cross-site project teams consistent with company objectives to improve overall compliance performance to established metrics and requirements
• Research emerging regulatory trends and changes in regulations and standards to incorporate into training programs.
• Monitor and evaluate training program’s effectiveness and periodically reports to senior management progress or issues.
• Utilize cost-effective, consistent and best-practice training methods and ensures compliance with both regulatory and internal compliance.
• Lead or support special quality and compliance projects as requested, and perform other assigned duties, as needed.
• Leads and supports communication and change management activities for training implementations.
• Collaborate with department management in the preparation of annual training plans and budgets.

Job Qualifications

Required:

• A minimum of a 4-year college degree (Bachelor’s Degree) or equivalent is required
• A minimum of 8 years of professional experience in the medical device or pharmaceutical industry is required
• A minimum of 8 years of developing and implementing training program experience in a medical device or pharmaceutical environment, preferably to global users.
• Knowledge and experience developing and implementing training programs using current and emerging training authoring tools preferred (e.g., Articulate 360, Brainshark)
• 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.
• Knowledge and experience with current and emerging Learning Technologies preferred.
• Project management experience strongly preferred particularly in the design implementation and sustainment of learning and performance initiatives/processes.
• Experience in working within or with Japanese companies is desirable.