Pre-Clinical Quality Assurance Specialist
hace 1 mes
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 DescriptionWe 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.
- 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.
- 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.
- 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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