Pre-Clinical Quality Assurance Specialist

hace 1 mes


Barcelona, Barcelona, España Galderma A tiempo completo

Galderma is a leading dermatology company that is dedicated to advancing the field through innovation and science. We are seeking a highly skilled Pre-Clinical Quality Manager to join our team.

Job Description

We are looking for a professional to ensure the quality and GLP compliance of Pre-Clinical Development activities sponsored by Galderma, as well as related processes and systems.

Key Responsibilities
  • Establish the R&D Auditing strategy dedicated to pre-clinical development activities related to Prescription, Aesthetics and Cosmetics Galderma sponsored projects.
  • Define, manage, implement and, as necessary, adapt with R&DQA/Innovation Quality partners the audit program.
  • Conduct internal and external audits.
  • Assure the compliance of pre-clinical development activities with the company outsourcing governance.
  • Contribute to the development and optimization of the Quality Management System dedicated to Pre-Clinical Development.
  • Support regulatory intelligence activities.
  • Provide appropriate training ensuring the buy-in by R&D employees of the quality management system and corresponding regulations and guideline.
  • Participate to the quality analyses of Galderma first-priority projects to identify any compliance trend that would potentially jeopardize the admissibility of their results by Competent Authorities.
  • Assure international inspection readiness of Galderma R&D activities and coordinate GLP regulatory inspections conducted by Competent Authorities world-wide.
Requirements
  • Effective experience in R&D activities and Quality Assurance.
  • Robust experience in R&D audits, inspections and development/implementation of Quality Management Systems.
  • Be familiar 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 professional development and growth within the company.
  • A diverse and inclusive work environment that values and respects individual perspectives.
Process Steps
  • Send your CV in English.
  • If your profile is a match, 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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