Senior Auditor, Quality Assurance

Job not on LinkedIn

🔥 0 minutes ago

🇪🇸 Spain – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 18%

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

• 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 area of GxP expertise • Conduct audits of Company partners, vendors, service providers, internal systems, study files, investigational sites, and third parties on behalf of Clients • Manage pre-audit activities effectively • Review and approve final CAPA plans from contracted audits within required timelines • Conduct Client PV/QMS system gap analyses and support SOP development • Serve as main QA contact for designated Clients and plan, conduct, and report on Client-requested audits • Attend commercial meetings related to Quality as a Service • Support Clients with mock inspections, training, gap analysis, and procedure drafting/revision • Support audits and inspections performed by Clients, third parties, and regulatory authorities • Develop and train Auditors and other quality employees with Quality leadership • Assist in developing the strategic internal audit program • Maintain current knowledge of international regulatory requirements, guidelines, and best practices • Participate in preparation, authoring, or QC of audit strategies, SOPs, guidelines, and other auditing 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 and GCP-related Quality Management and Assurance • Previous 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 option • Collaborative team of experts in clinical research, pharmacovigilance, and quality consulting • Continuous learning and development opportunities • Training and knowledge-sharing opportunities • Diverse and inclusive workplace • Opportunity to make a difference to patients’ lives