Quality Manager, GXP Training

Role Summary

We are seeking an experienced Quality Manager, GXP Training to lead GxP and general business training processes at Lantheus Medical Imaging, including ownership of the Electronic Learning Management System (ELMS). The position collaborates with internal stakeholders to develop and deliver training content, knowledge assessments, and On-the-Job Training (OJT) programs. It ensures training programs align with role-based training, company policies and regulatory requirements, drives continuous improvement, and supports organizational development initiatives.

Responsibilities

• Training Development & Delivery
• Design and facilitate site-wide and technical training, including cGMP content.
• Partner with subject matter experts to create and maintain training materials and assessments.
• Conduct new hire GMP training and support inspection readiness activities.
• Learning Management System (ELMS)
• Serve as business owner and subject matter expert for ELMS.
• Provide user support, assign training requirements, and maintain training records.
• Collaborate with IT to resolve system issues and implement enhancements.
• Training Operations & Compliance
• Maintain personnel training files and ensure documentation accuracy.
• Track training compliance and report performance metrics to management.
• Support GMP areas in developing and maintaining OJT programs.
• Organizational Development
• Conduct needs assessments and design development plans aligned with business priorities.
• Deliver core curriculum and customized training for managers and teams.
• Provide coaching, facilitate team-building sessions, and support succession planning.
• Strategic Initiatives
• Promote company mission, vision, and values through training programs.
• Evaluate and enhance training effectiveness, delivery methods, and content.
• Manage training resources, budgets, and external vendors as needed.

Qualifications

• Bachelor‚Äôs degree with 5+ years of training experience in a regulated environment (pharma/biotech preferred).
• Proficiency in courseware development, including eLearning/CBT design.
• Experience administering electronic learning management systems.
• Strong knowledge of cGMP and pharmaceutical industry regulations.
• Excellent communication, facilitation, and project management skills.
• Proficient in MS Word, Excel, and PowerPoint.
• Flexibility to support non-routine work hours as needed.

Skills

• Training development and delivery
• ELMS administration
• cGMP compliance and regulatory understanding
• Needs assessment and organizational development
• Coaching, facilitation, and team leadership
• Vendor management and budgeting

Education

• Bachelor‚Äôs degree (required) in a relevant field

Additional Requirements

• On-site presence required five days per week