Lead Pre-Clinical Quality Assurance Specialist

hace 1 mes


Barcelona, Barcelona, España Galderma A tiempo completo

About the Role

We are seeking a highly skilled Lead Pre-Clinical Quality Assurance Specialist to join our team at Galderma. In this role, you will be responsible for ensuring the quality and compliance of pre-clinical development activities sponsored by Galderma.

Key Responsibilities

  • Develop and implement an R&D auditing strategy dedicated to pre-clinical development activities related to prescription, aesthetics, and cosmetics projects.
  • Collaborate with R&DQA/Innovation Quality partners to define, manage, and adapt audit programs as necessary.
  • Conduct internal and external audits to ensure compliance with company outsourcing governance and regulatory requirements.
  • Assure international inspection readiness of Galderma R&D activities and coordinate GLP regulatory inspections conducted by competent authorities worldwide.
  • Support regulatory intelligence activities and contribute to the development and optimization of the Quality Management System dedicated to Pre-Clinical Development.
  • Provide training and support to R&D employees on quality management systems and corresponding regulations and guidelines.
  • Participate in quality analyses of Galderma first-priority projects to identify potential compliance trends that may jeopardize admissibility by competent authorities.

Required Skills and Qualifications

  • 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.

About the Opportunity

As a valued member of our team, you will enjoy a competitive compensation package with bonus structure and extended benefit package. You will also have the opportunity to work in a hybrid work culture and participate in feedback loops to establish a personalized career path. We believe in ownership from day one, empowering everyone to grow and take accountability.

Estimated Salary Range

$120,000 - $150,000 per year, depending on location and experience.



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