Senior Quality Specialist, Client Quality Management

🔥 6 minutes ago

🌐 New Zealand, Romania – Remote

🇳🇿 New Zealand – Remote 🇷🇴 Romania – 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 • Oversee all client quality-related activities for assigned projects • Collaborate with Quality Management, Quality Assurance, Audit Management, Project Managers and project teams • Ensure timely and complete employee training within client projects • Create and maintain project-specific quality management and training plans • Review regulatory intelligence reports and assess project impact • Ensure project procedures comply with global pharmacovigilance regulations, guidelines, SOPs and Joint Operating Guidelines • Review and contribute to project-related procedural documentation • Ensure project resources are qualified and personnel records are current • Establish and test Business Continuity Plans and Disaster Recovery Plans • Review and approve controlled-system access requests • Review backup, recovery logs and audit trails for project systems • Review training materials, monitor training completion and approve team members for live work • Gather and 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 project inspection readiness • Act as main contact for project audit activities, coordinate audit requests, responses and actions • Contribute to project risk assessments • Support deviation reporting, root cause analysis and categorisation • Ensure corrective and preventive actions and effectiveness assessments are proposed • Manage project deviations and CAPAs through timely completion

🎯 Requirements

• Life Sciences degree • Strong previous pharmacovigilance experience • Quality and compliance experience within a GxP environment • Good organisational skills • Attention to detail • Excellent communication skills • Good IT skills • Ability to manage a variety of clients with limited input • Ability to ensure compliance with global regulations, legislation, PrimeVigilance and client requirements

🏖️ Benefits

• Flexible work arrangements / remote work • Kindness, flexibility, growth and belonging culture • Collaborative team environment • Opportunity for professional growth • Global reach and purpose-driven work • Passionate and collaborative team of experts • Diverse and inclusive workplace • Employee referral program