GXP Document Control & Training Leader

Skyelia; Baltimore (MD); On-site; USD 95,000 - 125,000; Full time

Job summary

Skyelia is seeking a Manager, Document Control and Training to oversee the document management and Learning Management System operations, ensuring GMP/GxP compliance and operational support. You will lead daily activities of Document Control and Training, manage EDMS/LMS administration, develop engaging GMP training content, and mentor the Training team.

The role requires a life sciences or education-related bachelor's degree and 5+ years creating adult learning content; pharma/medical devices

Qualifications

• Minimum 5 years creating and delivering educational content to adult learners.
• Experience in regulated manufacturing industry preferred.
• Strong communication with senior management.
• Experience administering electronic learning and document management systems.
• Proficiency in instructional design and needs assessment.

Responsibilities

• Lead daily operations of Document Control and Training departments to ensure regulatory compliance and operational support.
• Manage Electronic Document Management System (EDMS) and Learning Management System (LMS) administration locally.
• Support batch record revision processes and develop engaging GMP training content.
• Conduct gap analyses to identify training needs and enhance processes.
• Mentor the Training team on LMS capabilities, training techniques, and process improvements.
• Drive continuous improvement initiatives for departmental processes.
• Act as site process owner (SPO) for EDMS, LMS, and associated SOPs, collaborating cross-functionally to mitigate impacts on other departments.
• Monitor key performance metrics and report findings to management.
• Stay updated on industry trends and regulatory standards to ensure compliance and best practices.
• Support client and regulatory audits, and participate in other Quality Systems activities as required.

Skills

Leadership

Communication

Educational content development

Adult learning theory

MS Office

Education

Bachelor's degree in life sciences or education-related field

Tools

EDMS

LMS

MS Office Suite

Job description

Skyelia is seeking a Manager, Document Control and Training to oversee the document management and Learning Management System operations, ensuring GMP/GxP compliance and operational support. You will lead daily activities of Document Control and Training, manage EDMS/LMS administration, develop engaging GMP training content, and mentor the Training team.

The role requires a life sciences or education-related bachelor's degree and 5+ years creating adult learning content; pharma/medical devices