Senior Quality Specialist, Client Quality Management

🔥 0 minutes ago

🌐 New Zealand, Croatia – Remote

🇳🇿 New Zealand – Remote 🇭🇷 Croatia – Remote

⏰ Full Time

🟠 Senior

✨ Quality Specialist

👻 Ghost score 17%

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

• Implement and maintain the quality system and training for assigned client projects • Ensure project compliance with global regulations, legislation, PrimeVigilance requirements, and client requirements • Oversee all client quality-related activities for assigned projects • Collaborate with Quality Management, Quality Assurance, Audit Management, Project Managers, and project teams • Manage multiple clients and deliver work with limited input • Ensure timely and complete employee training within client projects • Create and maintain project-specific quality management, training, and training matrix plans • Review regulatory intelligence reports and assess impacts on designated projects • Ensure project procedures align with pharmacovigilance regulations, guidelines, SOPs, and Joint Operating Guidelines • Review and contribute to project procedural documentation • Ensure project resources are qualified and personnel records remain current • Maintain and test Business Continuity Plans and Disaster Recovery Plans • Review and approve controlled-system access requests • Review backup, recovery logs, and audit trails • Review and approve project-specific training materials • Monitor training completion, competency tests, and authorization for live work • Monitor project metrics and KPIs and address issues or trends • Author quality and compliance sections of monthly project reports • Perform final time quality reviews on samples of processed cases • Maintain inspection readiness • Act as the main contact for project audit activities and coordinate audit responses and corrective actions • Contribute to project risk assessments • Support deviation reporting, root cause analysis, categorization, corrective actions, preventive actions, and effectiveness assessments • Manage project deviations and CAPAs through timely completion

🎯 Requirements

• Life Sciences degree • Strong previous pharmacovigilance experience, including quality and compliance experience within a GxP environment • Good organisational skills • Attention to detail • Excellent communication skills • Good IT skills

🏖️ Benefits

• Remote work option • Collaborative and supportive team culture • Flexible work environment • Growth opportunities • Belonging-focused workplace • Exposure to global pharmacovigilance, clinical research, and quality consulting teams