Pre-Clinical Quality Assurance Specialist

hace 6 días

Barcelona, Barcelona, España Galderma A tiempo completo
Galderma is a leading dermatology company with a rich legacy and a commitment to innovation. We are seeking a highly skilled Pre-Clinical Quality Manager to join our team.

**Job Summary**

We are looking for a professional to ensure the quality and GLP compliance of Pre-Clinical Development activities sponsored by Galderma.

**Key Responsibilities**

* Establish the R&D Auditing strategy for pre-clinical development activities related to Prescription, Aesthetics, and Cosmetics Galderma sponsored projects.
* Define, manage, implement, and adapt the audit program with R&DQA/Innovation Quality partners.
* Conduct internal and external audits.
* Ensure 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 training to ensure 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 trends that would potentially jeopardize the admissibility of their results by Competent Authorities.
* Ensure 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**

* A competitive compensation package with bonus structure and extended benefit package.
* A hybrid work culture.
* Feedback loops, during which a personalized career path will be established.
* A growing company that believes in ownership from day one, where everyone is empowered to grow and take on accountability.

**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.

**Our People Make a Difference**

At Galderma, you'll work with people who are like you. And people who are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

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