Senior Specialist, Quality Training

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide support for the training governance framework, policies, and standards associated with the GxP training program.

• Assist in the administration of the Learning Management System and collaborate with IT LMS system administrators on related processes.

• Act as the LMS business administrator to create, modify, and phase out training items, curricula, and training assignments within GxP functional areas.

• Organize and assist with regularly scheduled GxP/Quality onboarding training sessions for new employees.

• Oversee, monitor, and prioritize training requests for curricula and course management, training assignments, and reporting.

• Collaborate with functional leaders across the organization to identify enterprise-wide, role-based training needs and implement them in the LMS.

• Collect and provide training data for departmental communications or the Quality Management Review process.

• Assist in the management of records for both physical and electronic training and qualification documentation.

• Support audits and inspections of the training program and provide assistance during regulatory inspections.

• Contribute to governance, regulatory compliance, LMS, and training performance outcomes organization-wide.

• Aid the Quality Training Lead in executing GxP learning strategies and ensuring regulatory training compliance.

• Report directly to the Associate Director of Quality Training.

⛳️ Requirements

• 3–5 years of progressive experience within the biotech or pharmaceutical sectors.

• Over 2 years of experience supporting GxP training programs, LMS management, or Quality Systems.

• General understanding of adult learning theories, instructional design, and project management methodologies.

• Familiarity with global GxP regulations, including FDA, EMA, and ICH standards.

• Knowledge of learning management systems as well as quality systems.

• Business acumen related to Clinical Research, Development, and Manufacturing in the pharmaceutical field.

• Experience in one or more GxP disciplines: GMP, GCP, GLP, or GDP.

• Proficiency in LMS administration and processing tasks.

• Exceptional written and verbal communication capabilities.

• Strong organizational skills.

• Proficient in Microsoft Office (Outlook, OneNote, Excel, Word, PowerPoint), Adobe Acrobat, and survey tools.

• Understanding of good documentation practices.

• Capable of sedentary work and accustomed to typical office/administrative environments.

🏝️ Benefits

• Hourly compensation ranging from $55.00 to $64.00.

• Option for remote work.

• Protections under equal employment opportunity laws.

• Protections for Veterans and Individuals with Disabilities.