Quality Specialist, Quality Process – LMS Administration

This is a fully remote position, open to applicants in Serbia, +1 more country.

📋 Description

• Provide support and guidance to colleagues and functional teams in the development, management, and implementation of Controlled Procedures.

• Ensure compliance with GxP activities in accordance with relevant legislation, guidelines, and standards, including ICH, CIOMS, and ISO.

• Serve as a Subject Matter Expert for GxP Quality Operations, Training regulations, and the Ergomed Quality Management System as needed.

• Assist in facilitating GxP training initiatives throughout the Ergomed Group.

• Ensure that employees receive adequate training to fulfill global GxP requirements and meet client expectations.

• Monitor training activities until completion and collaborate with Learning and Development.

• Aid in the triage and management of access processes for the Ergomed Group Quality Management System.

• Engage in efficiency projects aimed at enhancing the use and management of the Quality Management System.

• Review and authorize access requests to Controlled Systems for both employees and clients.

• Contribute to Business Continuity initiatives across the Ergomed Group.

• Assist with audits and inspections by providing necessary Quality Management System reports or procedures.

• Prepare and analyze Quality Operations and Training metrics, delivering periodic management reports.

• Generate CAPA or Deviation records arising from issues in Controlled Document, GxP Training, and BCP processes.

• Mentor and lead the Quality Process and Training team.

• Cultivate the competence, confidence, and subject matter expertise of team members.

• Promote a collaborative quality culture across global teams and regions.

• Offer coaching and professional development to enhance team capability and succession planning.

⛳️ Requirements

• A university degree in Biomedical sciences, Natural sciences, or Health Sciences is mandatory.

• A background in Nursing, Pharmacy, or a BS/Master’s degree in a scientific discipline, or relevant experience is acceptable.

• Experience in LMS administration is required.

• Familiarity with GxP training activities and requirements is essential.

• Knowledge of Controlled Procedures and Quality Management Systems is necessary.

• Understanding applicable legislation, guidelines, and standards, including ICH, CIOMS, and ISO is crucial.

• Experience or capability in managing controlled systems access requests is important.

• Proficiency in preparing and analyzing Quality Operations and Training metrics is required.

• Ability to create CAPA or Deviation records is necessary.

• Capacity to support audits and inspections is essential.

• Relevant experience may be considered in lieu of the specified degree requirement.

🏝️ Benefits

• Option for remote work.

• Emphasis on work-life balance.

• Collaborative environment with an international team.

• Opportunities for career advancement.

• Flexible working conditions.

• Access to coaching and professional development opportunities.

• Supportive organizational culture.

• Empowerment through trusted ownership and responsibility.