Corporate GCP/GVP Quality Assurance-R&D Center Sant Feliu de Llobregat 1 - SFEL - R&D SANT FELIU DE LLOBR, España - Almirall

Descripción

Mission

Provide advice, maintenance, oversight, and continuous improvement of the Almirall GCP Quality Management System, ensuring compliance with applicable regulations and guidelines.

Functions and responsibilities

• Establish and maintain a Quality System for Clinical Trial activities, aligning with the relevant departments to ensure compliance with applicable regulations.
• Develop GCP global quality plans, audit plans, and risk mitigation strategies based on risk assessments. Coordinate, document, and follow up on defined audits. Lead, assist or oversight with audit activities as necessary.
• Lead the preparation and management of inspections by Competent Authorities and audits performed by third parties to Almirall.
• Identify and communicate quality and regulatory compliance issues to the relevant management and recommending remediation.
• Participate in Clinical Study Teams and specific Project Teams.
• Select, coordinate, and oversee outsourced QA activities applicable to clinical trials.
• Stay updated with current regulations, standards, and guidance documents. Contribute to technical guidance, leadership, mentoring, and training as a key stakeholder in quality and compliance matters.

Education

• Bachelor's/Master's degree in Health Sciences, Biological Sciences, or a related field.

Experience and requirements

• Minimum of 5 years of experience in GCP.
• Knowledge of GVP is a plus.
• Experience in dealing with Health Authority inspections and audits by external parties.
• Willingness to travel up to 15% of the time.
• Fluency in English, both written and spoken, is essential.
• Detail-oriented and analytical mindset with a clear focus on meeting timelines and objectives.