Role Description

You will manage QMS training-related processes, systems (Learning Management System), and departmental resources to ensure all QMS training content and delivery methods comply with applicable regulatory standards and internal quality procedures.

• Support company growth by driving improvement initiatives geared towards simplification, standardization, and overall effectiveness of our QMS training programs.
• Proactively identify improvement opportunities through data analysis such as gap assessments, internal feedback, external benchmarking, and the use of available technology.
• Guide the QA Training Department to implement larger change projects through robust planning, analysis, stakeholder collaboration, risk-mitigation, tracking, and documentation.
• Provide status updates and performance data related to sustaining activities, improvement projects, and compliance assessments.
• Be a hands-on people-leader who fosters open communication and a proactive approach to ensure efficient workflow and continual review for compliance risks.

Qualifications

• Typically requires a Bachelor’s degree with 8-12 years of industry experience.
• 2-5 years of previous management or lead experience.

Requirements

• Held role(s) with direct responsibility for managing QMS processes regulated by FDA or similar industry, preferably with some responsibilities for personnel training.
• Positive, organized leader who values transparency and is open to input while maintaining accountability to achieve results.
• Passionate about team success with clear expectations, empowerment, coaching, and recognition.
• Customer-service oriented and eager to build strong relationships with internal stakeholders.
• Apply critical thinking and change management skills to solve problems, make decisions, and drive desired results.
• Familiar with FDA 21 CFR Part 11 requirements applied to enterprise software systems.

Benefits

• A front row seat to life changing CGM technology.
• Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.