Pre-Clinical Quality Assurance Specialist

hace 2 semanas

Barcelona, Barcelona, España Galderma Pharma S.A A tiempo completo
Job Title: Pre-Clinical Quality Manager

Galderma Pharma S.A is seeking a highly skilled Pre-Clinical Quality Manager to join our team. As a key member of our R&D organization, you will be responsible for ensuring the quality and GLP compliance of pre-clinical development activities sponsored by Galderma.

Key Responsibilities:
  • Establish the R&D auditing strategy for pre-clinical development activities related to prescription, aesthetics, and cosmetics Galderma-sponsored projects.
  • Define, manage, implement, and adapt the audit program with R&D QA/Innovation Quality partners.
  • Conduct internal and external audits to ensure compliance with company outsourcing governance.
  • Contribute to the development and optimization of the Quality Management System dedicated to Pre-Clinical Development.
  • Support regulatory intelligence activities and provide training to R&D employees on quality management systems and corresponding regulations.
  • Participate in quality analyses of Galderma first-priority projects to identify compliance trends that may impact admissibility by Competent Authorities.
  • Ensure international inspection readiness of Galderma R&D activities and coordinate GLP regulatory inspections conducted by Competent Authorities worldwide.
Requirements:
  • Effective experience in R&D activities and Quality Assurance.
  • Robust experience in R&D audits, inspections, and development/implementation of Quality Management Systems.
  • Familiarity with R&D IT environment, tools (Documentum platform, Trackwise, Trial Interactive...), and validation approach (GAMP, 21CFR part 11...).
  • Confirmed expertise in Good Laboratory Practices and associated regulations.
What We Offer:
  • A competitive compensation package with bonus structure and extended benefit package.
  • A hybrid work culture that allows for flexibility and work-life balance.
  • Opportunities for growth and development within a growing company that values ownership and accountability.

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