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Pre-Clinical Quality Assurance Manager
hace 2 meses
Company Overview
Galderma is a leading dermatology company with a rich legacy and a commitment to innovation. We deliver a portfolio of premium brands and services that cater to the diverse needs of the dermatology market.
Job Summary
We are seeking a highly skilled Pre-Clinical Quality Assurance Manager to join our team. The successful candidate will be responsible for ensuring the quality and compliance of pre-clinical development activities sponsored by Galderma.
Key Responsibilities
- Establish and implement a robust R&D auditing strategy for pre-clinical development activities.
- Define and manage the audit program in collaboration with R&DQA/Innovation Quality partners.
- Conduct internal and external audits to ensure compliance with company policies and regulations.
- Assure the compliance of pre-clinical development activities with outsourcing governance.
- Contribute to the development and optimization of the Quality Management System dedicated to Pre-Clinical Development.
- Support regulatory intelligence activities and provide training on quality management systems and regulations.
- 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.
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, and validation approach.
- 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 that promotes work-life balance.
- Opportunities for professional growth and development.
- A diverse and inclusive work environment that values collaboration and teamwork.
