Lead Pre-Clinical Quality Assurance Specialist
hace 1 mes
About the Role
We are seeking a highly skilled Lead Pre-Clinical Quality Assurance Specialist to join our team at Galderma. In this role, you will be responsible for ensuring the quality and compliance of pre-clinical development activities sponsored by Galderma.
Key Responsibilities
- Develop and implement an R&D auditing strategy dedicated to pre-clinical development activities related to prescription, aesthetics, and cosmetics projects.
- Collaborate with R&DQA/Innovation Quality partners to define, manage, and adapt audit programs as necessary.
- Conduct internal and external audits to ensure compliance with company outsourcing governance and regulatory requirements.
- Assure international inspection readiness of Galderma R&D activities and coordinate GLP regulatory inspections conducted by competent authorities worldwide.
- Support regulatory intelligence activities and 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 corresponding regulations and guidelines.
- Participate in quality analyses of Galderma first-priority projects to identify potential compliance trends that may jeopardize admissibility by competent authorities.
Required Skills and Qualifications
- 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.
About the Opportunity
As a valued member of our team, you will enjoy a competitive compensation package with bonus structure and extended benefit package. You will also have the opportunity to work in a hybrid work culture and participate in feedback loops to establish a personalized career path. We believe in ownership from day one, empowering everyone to grow and take accountability.
Estimated Salary Range
$120,000 - $150,000 per year, depending on location and experience.
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