Senior Specialist

Administer, maintain, and continuously improve GxP learning systems and training processes Serve as the primary subject matter expert for learning technologies, training compliance reporting, and data governance Administer training content and align training assignments with business and compliance requirements Provide advanced user support and troubleshooting for learning systems and processes Lead LMS configuration, vendor relationships, security roles, data architecture, integrations, reporting structures, and system lifecycle management Analyze metrics, audit observations, system performance, and stakeholder feedback to optimize workflows, data management, and user experience Support regulatory inspections, audits, and quality assessments by preparing and retrieving training records and documentation Lead or support learning system enhancement, implementation, harmonization, migration, and continuous improvement initiatives Coordinate vendor releases, system upgrades, integrations, and LMS-related projects Design and execute user acceptance testing, system testing, and validation activities Lead onboarding and training of LMS Administrators Develop and maintain procedures, work instructions, training materials, and system documentation Assist with training dashboards and program metrics Participate in cross-functional committees, project teams, and quality initiatives Support training communications, end-user education, learning content deployment, and course maintenance Mentor junior team members and provide subject matter expertise Support vendor management and external consultant engagements Work with sites, functions, management, IT, quality validation, and vendors to maintain the LMS in a validated state Requirements 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 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 Technical learning systems expertise Data integrity and compliance focus Analytical thinking and problem solving Project management Attention to detail Collaboration and teamwork Communication skills Continuous improvement mindset Adaptability and change agility Core Competencies Demonstrates expertise in administering and improving GxP learning systems, with a strong focus on compliance, data governance, and training processes. Proficient in managing vendor relationships, system validation, and regulatory requirements while fostering collaboration and continuous improvement. Highest-signal resume keywords GxP Training Program Support ComplianceWire Administration Computerized System Validation Learning System Implementation Regulatory Requirements Knowledge ATS Optimization Keywords Hard Skills GxP Learning Systems Administration ComplianceWire Computerized System Validation Learning Analytics Dashboard Development Data Governance Training Content Management User Acceptance Testing System Lifecycle Management Quality Management Systems Soft Skills Analytical Thinking Problem Solving Attention to Detail Collaboration Communication Industry Keywords 21 CFR 820 21 CFR 211 ISO 13485 Change Control Training Compliance Reporting Tools & Technologies Learning Management System (LMS) Data Management Systems Training Dashboards Vendor Management Tools Quality Validation Tools #J-18808-Ljbffr