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Our purpose is simple: to transform patients' lives by addressing real needs. We work with care, act with courage, keep things simple and focus our innovation where it makes a difference.

Recognised as a Top Employer in Spain since 2008 and in Germany since 2025, we continue to invest in an environment where people can grow and move forward.

If you care differently, you belong here.

POSITION SUMMARY / MISSION

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

CORE RESPONSIBILITIES

• Collaborate in establishing and maintenance of the Quality System for Clinical Trial and Pharmacovigilance activities, aligning with the relevant departments to ensure compliance with applicable regulations and in accordance with Almirall policies.
• Develop GCP and GVP global quality plans and programs, audit plans, and risk mitigation strategies based on risk assessments. Coordinate, document, and follow up on defined audits. Lead, assist or oversight the audit activities as necessary.
• Support the preparation and management of inspections by Competent Authorities and audits performed by third parties to Almirall.
• Identify and report quality and regulatory compliance concerns to the appropriate management, providing recommendations for remediation.
• QA advisor in Clinical Study Teams and specific Project Teams.
• Select, coordinate, and oversee outsourced QA activities applicable to clinical trials.
• Key influencer in quality and compliance GCP initiatives, consistently staying updated with the latest regulations, standards, and guidance documents, providing technical leadership, and training to maintain the highest standards on the field.
• Audit GVP and GCP compliance activities including Quality Control, Production, Distribution, Maintenance/Engineering and outsourced companies for these activities.
• To review and approve procedures and any other key documents related to pharmacovigilance or clinical trials ensuring alignment and compliance with current applicable regulations.
• Draft QA procedures applicable to Drug Safety or Clinical trials activities and quality system.
• Keep up to date with new regulations impacting Clinical trials and Pharmacovigilance.
• Collaborate with GxP training of staff.

REQUIRED EDUCATION AND EXPERIENCE

• Life-Science Degree.
• Knowledge of Quality Normatives (GCP, GVP, relevant ICH, etc.).
• Courses in R&D Quality Assurance in pharmaceutical companies.
• Knowledge of systems and computer networks.
• Proficiency in computer programs.
• Ability to draft scientific texts.
• Proficiency in English.
• Two years of experience in QA for Clinical trials and/or Pharmacovigilance.

PREFERRED SKILLS & COMPETENCES

• Understanding of GVP and GCP compliance and auditing processes.
• Attention to detail and ability to verify documentation accuracy.
• Analytical and problem-solving skills.
• Ability to collaborate across teams and train staff.
• Proficiency quality management systems.
• Commitment to safety and continuous improvement.

QA MANAGER GVP/GCP in QA R&D and COMMERCIAL PRODUCT DEVELOPMENT