Senior Auditor, Quality Assurance – Pharmacovigilance Audit, GCP Audit

🔥 13 minutes ago

🇪🇸 Spain – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 18%

What it means: the chance that no one is really hiring for this job.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

• Manage and conduct internal and contracted audits for the Company and its clients • Provide input into audit strategy and risk-based audit planning • Lead process and complex audits • Provide QA consultancy within the area of GxP expertise • Manage pre-audit activities • Conduct audits of company partners, vendors, service providers, internal systems, study files, investigational sites, and third parties on behalf of clients • Review and approve final CAPA plans within mandated timelines • Serve as the main QA contact for designated clients • Plan, conduct, and report on client-requested audits • Attend commercial meetings related to Quality as a Service • Support mock inspections, training, gap analysis, procedure drafting, and revision • Support company audits and inspections performed by clients, third parties, and regulatory authorities • Develop and train auditors and other quality employees • Assist in developing the strategic internal audit program • Maintain up-to-date knowledge of international regulatory requirements, guidelines, and best practices • Participate in knowledge-sharing and continuous learning activities • Author or quality-control audit strategies, SOPs, guidelines, and other audit procedures

🎯 Requirements

• Bachelor’s degree in a scientific discipline required; Master’s degree preferred, or equivalent relevant industry experience • Strong previous pharmaceutical and/or biotech pharmacovigilance experience • Strong understanding of GVP & GCP related Quality Management and Assurance • Previous experience of GVP and GCP auditing experience in an Audit Lead role • Analytical, written and oral communication skills • Ability to manage assigned tasks and deliver expected deliverables in an organized and timely manner • Ability to proactively communicate changes in pre-established goals and deadlines • Ability to think strategically and work collaboratively using risk-based, proactive approaches to problem-solving • Strong team player • Fluent in English, written and spoken • Additional/local languages are a plus, but not required

🏖️ Benefits

• Remote work availability • Collaborative team environment • Professional growth and continuous learning opportunities • Training and development opportunities • Opportunity to make a difference to patients' lives • Diverse and inclusive workplace • Passionate team of clinical research, pharmacovigilance, and quality consulting experts

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