h3Quality GCP Auditor - Relocate to Madrid? /h3pOpen to individuals already located in or willing to relocate to Madrid. /pp4 days a week onsite in Madrid. /ppstrongGeneral Responsibility /strong /ppThe 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. /ppAdditionally, the specialist will support the General 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. /ppstrongSpecific Responsibilities /strong /pulliLead and manage validation activities for eClinical systems, ensuring regulatory compliance. /liliEstablish, implement, and maintain the Global/Corporate Clinical Quality Assurance System. /liliSupport the development and maintenance of Quality Assurance Systems across business units and affiliated units within the company group. /liliDevelop and implement quality assurance processes and validation documentation, including plans, protocols, reports, and SOPs. /liliConduct risk assessments and implement mitigation strategies for eClinical systems.



/liliLead and conduct qualification and vendor audits of CROs and third-party vendors for clinical trial activities. /liliAssist in external and internal audits, inspections, and vendor qualifications. /liliSupport the selection and implementation of new Clinical systems and maintain a Global Clinical vendor/service provider database. /liliOversee the follow-up on Corrective and Preventive Actions (CAPA) from audits and vendor qualifications. /liliMaintain the Corporate Auditing Management electronic system for tracking audits from initiation to closure. /liliProvide training and support on CSV processes and regulatory requirements. /li /ulpstrongRequirements Personal Skills /strong /pullistrongEducation: /strong Bachelor's degree in Life Sciences (e.g., Chemistry, Pharmacy, Biology, Medicine), Computer Science, or a related field. A Master’s degree is a plus. /lilistrongLanguages: /strong Fluent in English; additional languages are a plus. /lilistrongExperience: /strong 3-5 years of experience in computer system validation within the pharmaceutical or clinical research industry. /lilistrongKnowledge: /strong Strong understanding of regulatory requirements (FDA, EMA) and industry standards. /lilistrongTravel: /strong Willingness to travel up to 30% to clinical research units, biolabs, and company locations. /li /ulpEmail applicants: /ph3Seniority level /h3pMid-Senior level /ph3Employment type /h3pFull-time /ph3Job function /h3pResearch, Quality Assurance, and Accounting/Auditing /ph3Industries /h3pPharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing /p #J-18808-Ljbffr

📌 Quality GCP Auditor - Relocate to Madrid-
🏢 Discover International
📍 Madrid