Quality GCP Auditor
- Relocate to Madrid? General ResponsibilityThe Clinical Quality Auditor ensures the validation and compliance of eClinical systems, including Interactive Response Technology (IRT), Clinical Trial Management Systems (CTMS), Case Report Forms (CRF), Trial Master Files (TMF), Clinical Outcome Assessments (COA), and electronic Patient-Reported Outcomes (ePRO). This role involves cross-functional collaboration to uphold quality and regulatory compliance standards.
Additionally, the specialist will support the Global Quality Unit in developing, implementing, and maintaining the companies Clinical Quality System, ensuring compliance with GCP, GLP/GMP guidelines, EMA and FDA/CFR regulations, and other applicable standards.
Establish, implement, and maintain the Global/Corporate Clinical Quality Assurance System.
Support the development and maintenance of Quality Assurance Systems across business units and affiliated units within the company group.
Develop and implement quality assurance processes and validation documentation, including plans, protocols, reports, and SOPs.




Lead and conduct qualification and vendor audits of CROs and third-party vendors for clinical trial activities.
Assist in external and internal audits, inspections, and vendor qualifications.
Support the selection and implementation of new Clinical systems and maintain a Integral Clinical vendor/service provider database.
Oversee the follow-up on Corrective and Preventive Actions (CAPA) from audits and vendor qualifications.
Maintain the Corporate Auditing Management electronic system for tracking audits from initiation to closure.
Provide training and support on CSV processes and regulatory requirements.
Requirements & Personal SkillsEducation: Bachelor's degree in Life Sciences (e.
A Master's degree is a plus.
Languages: Fluent in English; additional languages are a plus.
Seniority levelMid-Senior levelEmployment typeFull-timeJob functionResearch, Quality Assurance, and Accounting/AuditingIndustriesPharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing

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