Pre-Clinical Quality Assurance Manager

hace 3 semanas

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

Galderma is a leading dermatology company that is committed to advancing the field through innovation and excellence. We are seeking a highly skilled Pre-Clinical Quality Manager to join our team and contribute to the success of our organization.

Job Summary:

The Pre-Clinical Quality Manager will be responsible for ensuring the quality and compliance of pre-clinical development activities sponsored by Galderma. This includes establishing the R&D auditing strategy, defining and implementing the audit program, conducting internal and external audits, and ensuring compliance with company outsourcing governance.

Key Responsibilities:
  • Develop and implement a comprehensive R&D auditing strategy to ensure the quality and compliance of pre-clinical development activities.
  • Collaborate with R&DQA/Innovation Quality partners to define, manage, and implement the audit program.
  • Conduct internal and external audits to ensure compliance with company policies and regulations.
  • Ensure the compliance of pre-clinical development activities 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 any compliance trends that may impact the admissibility of results 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, and validation approach.
  • 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 professional development and growth within the company.
  • A diverse and inclusive work environment that values employee well-being and satisfaction.
How to Apply:
  • Send your CV in English.
  • If your profile matches the requirements, we will invite you for a first virtual conversation with Talent Acquisition.
  • The next step is a virtual conversation with the hiring manager.
  • The final step is a panel conversation with the extended team.

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