Quality GCP Auditor - Relocate to Madrid-

Discover International; Madrid; Presencial; EUR 40.000 - 75.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Quality GCP Auditor to join their team in Madrid. This role is pivotal in ensuring the validation and compliance of eClinical systems, including IRT and CTMS. You will lead validation activities, support the development of Quality Assurance processes, and conduct audits to uphold regulatory standards. If you have a strong background in computer system validation and a passion for quality assurance in the pharmaceutical sector, this is an exciting opportunity to make a significant impact in a dynamic environment. Join a forward-thinking company that values expertise and innovation in clinical research.

Formación

• 3-5 years of experience in computer system validation in pharma or clinical research.
• Strong understanding of regulatory requirements (FDA, EMA) and industry standards.

Responsabilidades

• Lead validation activities for eClinical systems ensuring regulatory compliance.
• Develop and maintain Quality Assurance Systems across business units.

Conocimientos

Computer System Validation

Regulatory Compliance

Risk Assessment

Quality Assurance Processes

Cross-Functional Collaboration

Educación

Bachelor's degree in Life Sciences

Master’s degree in related field

Herramientas

eClinical Systems

Clinical Trial Management Systems (CTMS)

Interactive Response Technology (IRT)

Descripción del empleo

Quality GCP Auditor - Relocate to Madrid?

Open to individuals already located in or willing to relocate to Madrid.

4 days a week onsite in Madrid.

General Responsibility

The 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.

Specific Responsibilities

• Lead and manage validation activities for eClinical systems, ensuring regulatory compliance.
• 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.
• Conduct risk assessments and implement mitigation strategies for eClinical systems.
• 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 Global 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 Skills

• Education: 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.
• Languages: Fluent in English; additional languages are a plus.
• Experience: 3-5 years of experience in computer system validation within the pharmaceutical or clinical research industry.
• Knowledge: Strong understanding of regulatory requirements (FDA, EMA) and industry standards.
• Travel: Willingness to travel up to 30% to clinical research units, biolabs, and company locations.

Email applicants: [e-mail]

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Research, Quality Assurance, and Accounting/Auditing

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing