Pre-Clinical Quality Manager
hace 4 semanas
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 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.
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.
What we offer in return
You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
You will receive a competitive compensation package with bonus structure and extended benefit package
You will be able to work in a hybrid work culture
You will participate in feedback Loops, during which a personalized career path will be established
You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability
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