Job Description SummaryThe Senior Specialist, Learning Management Systems is responsible for the administration, maintenance, and continuous improvement of GxP learning systems and training processes. This role serves as the primary subject matter expert for learning technologies, training compliance reporting, and data governance. The position partners closely with Quality, Information Technology, Human Resources, and business stakeholders to ensure compliant and effective management of training records and learning programs. Additionally, this role plays a critical role in training system harmonization, implementation, validation, and data migration activities.
Job DescriptionLMS Administration & Operations- Serve as primary administrator and subject matter expert for Learning Management Systems (LMS) and related learning technologies for corporate and multiple sites.
- Administer training content in the LMS and ensure training assignments align with business and compliance requirements.
- Provide advanced user support and troubleshooting for learning systems and processes.
- Serve as system owner delegate and technical lead for LMS configuration, vendor relationship, security roles, data architecture, integrations, reporting structures, and system lifecycle management.
- Drive continuous improvement of learning systems and training administration processes by analyzing metrics, audit observations, system performance, and stakeholder feedback to identify opportunities to standardize, streamline, and optimize workflows, data management, and user experience.
- Support regulatory inspections, audits, and quality assessments through preparation and retrieval of training records and documentation.
LMS Strategy, Harmonization and Continuous Improvement- Lead or support learning system enhancement, implementation, harmonization, migration, and continuous improvement initiatives.
- Evaluate, coordinate, and manage vendor releases, system upgrades, integrations, and other LMS-related projects to ensure compliance, functionality, and business continuity.
- Design and execute user acceptance testing (UAT), system testing, and validation activities for learning technologies.
- Lead onboarding and training of LMS Administrators, ensuring consistent understanding of system functionality, processes, and best practices.
- Develop and maintain procedures, work instructions, training materials, and system documentation related to learning systems and processes.
Other Functions - Assist with development/maintenance of training dashboards and program metrics.
- Participate in cross-functional committees, project teams, and quality initiatives.
- Assist with training communications and end-user education related to system enhancements.
- Support learning content deployment and course maintenance activities.
- Mentor junior team members and provide subject matter expertise on learning systems and compliance processes.
- Support vendor management and external consultant engagements related to learning technologies.
Education & Experience- Bachelor's degree or equivalent experience in Life Sciences, Quality, Information Systems, or a related field.
- 6-8 years of experience supporting global or multi-site GxP training programs and processes.
- Minimum of 6 years of experience with the advanced administration of ComplianceWire.
- Demonstrated experience with computerized system validation principles and documentation.
- Demonstrated experience with learning system harmonization, implementation, or transformation projects.
- Experience supporting multi-site or global training programs.
- Experience with learning analytics and dashboard development
Knowledge- Thorough understanding of regulatory requirements associated with change control and software validation (e.g., 21 CFR 820, 21 CFR 211, ISO 13485).
- Understanding and knowledge of Quality Management Systems and document management systems.
Skills & Abilities- Technical Learning Systems Expertise
- Data Integrity and Compliance Focus
- Analytical Thinking, Problem Solving
- Project Management
- Attention to Detail
- Collaboration and Teamwork
- Communication Skills
- Continuous Improvement Mindset
- Adaptability and Change Agility
Working Conditions- This is a hybrid role. Normal office conditions. Occasional travel required.
Scope of AuthorityInternal Contacts
- Work with all sites, functions, and levels of management to assure proper assignment and documentation of all training activities.
- Work with IT and quality validation to maintain the LMS in a validated state.
External Contacts
- Collaborate with vendor to troubleshoot and maintain the LMS in a validated state.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
