Quality Specialist, Quality Process – LMS Administration

🔥 3 minutes ago

🌐 Serbia, India – Remote

🇷🇸 Serbia – Remote 🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🖥️ Administration

👻 Ghost score 16%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Support and guide colleagues and functional teams in developing, managing, and implementing Controlled Procedures • Ensure GxP activities comply with applicable legislation, guidelines, and standards, including ICH, CIOMS, and ISO • Act as a Subject Matter Expert for GxP Quality Operations, Training regulations, and the Ergomed Quality Management System as required • Assist in driving GxP training activities across the Ergomed Group • Ensure employees are adequately trained to meet global GxP requirements and client expectations • Track training activities through completion and partner with Learning and Development • Assist with triage and management of access processes for the Ergomed Group Quality Management System • Participate in efficiency projects improving Quality Management System use and management • Review and approve access requests to Controlled Systems for employees and clients • Assist with Business Continuity activities across the Ergomed Group • Support audits and inspections by supplying Quality Management System reports or procedures • Prepare and analyze Quality Operations and Training metrics and provide periodic management reports • Prepare CAPA or Deviation records resulting from issues in Controlled Document, GxP Training, and BCP processes • Mentor and lead the Quality Process and Training team • Develop team members’ competence, confidence, and subject matter expertise • Foster a collaborative quality culture across global teams and regions • Provide coaching and professional development to support team capability and succession planning

🎯 Requirements

• University degree in Biomedical sciences, Natural sciences or Health Sciences is required • Nursing, Pharmacy, or a BS/Master’s degree in a scientific discipline, or suitable experience • LMS administration experience required • Knowledge of GxP training activities and requirements • Knowledge of Controlled Procedures and Quality Management Systems • Understanding of applicable legislation, guidelines, and standards, including ICH, CIOMS, and ISO • Experience or capability in managing controlled systems access requests • Ability to prepare and analyze Quality Operations and Training metrics • Ability to prepare CAPA or Deviation records • Ability to support audits and inspections • Suitable experience may substitute for the stated degree requirement

🏖️ Benefits

• Remote work option • Work-life balance • Collaborative, international team environment • Career growth opportunities • Flexible work environment • Coaching and professional development opportunities • Supportive culture • Trusted ownership and responsibility