Quality Assurance Manager
il y a 6 heures
Santen is a specialized life sciences company with a rich history of innovation in ophthalmology. As a Quality Assurance Manager, you will play a critical role in ensuring the quality and compliance of our clinical development projects, products, and programs.
Key Responsibilities:- Assist with oversight of Quality and compliance with clinical development projects, products, and programs.
- Promote Quality culture throughout Santen.
- Collaborate with the Clinical Department, Pharmacovigilance/Safety Vigilance EMEA, APAC, and other functional areas on the implementation of the Santen Quality Management System.
- Provide guidance to Clinical Operations, Data Management, clinical supply, and Drug Safety to develop their self-inspection activities.
- Support Clinical Operations with quality-related issues and provide guidance when necessary.
- Implement and maintain the Quality Management System in the GCP area in accordance with local and global requirements.
- Develop, maintain, and follow up quality metrics for GCP in collaboration with Clinical Operations, Data Management, and Drug Safety.
- Perform QA assessment of Contract Research Organizations and external service providers.
- Prepare and deliver periodic reports based on metrics and quality trends.
- Participate in all health authority inspections at Santen sites as part of the global QA team.
- Conduct GCP training for R&D employees according to company policy.
- Minimum of 10+ years' experience in Clinical Quality Assurance and/or GPvP Assurance.
- Bachelor's degree in the scientific field or related healthcare provider.
- Excellent technical knowledge of GCP QA, GPvP QA, and quality assurance techniques.
- Strong organizational, time management, and project management skills.
- Proficient in the Microsoft Office software suite and other relevant computer applications.
We are committed to being a Social Innovator, addressing the social and economic needs of people with visual impairments.
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