Pre-Clinical Quality Manager

Job Description
We are looking for a professional 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, 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 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.
Skills & Qualifications
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.

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