Quality Assurance Expert for Pre-Clinical Development
hace 1 semana
Company Overview: Galderma is the world's largest independent dermatology company, present in approximately 100 countries. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care, and Prescription Medicine.
About the Job: We are looking for a Quality Assurance Expert to assure 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 adapt with R&D QA/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 guidelines.
- Participate in 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 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: You will receive a competitive compensation package with a salary range of $120,000 - $160,000 per year, depending on your experience. This includes a 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.
Culture: At Galderma, we value professionalism, collaboration, and a friendly, supportive ethos. Our people make a difference, and we strive to create an inclusive environment where everyone can thrive and excel in their role.
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