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Pre-Clinical Quality Assurance Manager
hace 2 meses
We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Galderma Pharma S.A. as a Pre-Clinical Quality Assurance Manager. This is an exciting opportunity to work in a dynamic and innovative environment, where you will be responsible for ensuring the quality and compliance of pre-clinical development activities.
Key Responsibilities- Establish and implement a robust R&D auditing strategy for pre-clinical development activities.
- Define, manage, and implement the audit program in collaboration with R&D QA/Innovation Quality partners.
- Conduct internal and external audits to ensure compliance with company outsourcing governance.
- Assure the compliance of pre-clinical development activities with regulatory requirements.
- Contribute to the development and optimization of the Quality Management System dedicated to Pre-Clinical Development.
- Provide training and support to R&D employees on quality management systems and regulatory requirements.
- Participate in quality analyses of Galderma's first-priority projects to identify potential compliance trends.
- Ensure international inspection readiness of Galderma R&D activities and coordinate GLP regulatory inspections.
- 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, and validation approach.
- 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 promotes work-life balance.
- Opportunities for professional growth and development.
- A dynamic and innovative work environment.
