Director of Quality Assurance
4 days ago
ProBio Overview
ProBio is a state-of-the-art Contract Development and Manufacturing Organization (CDMO) providing end-to-end services from drug discovery to commercialization. We leverage our expertise in cell and gene therapy, vaccine, biologics discovery and antibody protein drug development to accelerate customer success.
Quality Management at ProBio
The Director of Quality Assurance will lead the quality management function at ProBio, promoting the construction and optimization of our quality system. Key responsibilities include:
- Promoting the maintenance and continuous improvement of the quality management system
- Responsible for managing and optimizing quality documentation, materials, suppliers, changes, and CAPA systems
- Organizing internal and external quality system audits
- Identifying on-site problems/potential problems through daily supervision and ensuring timely rectification
- Participating in product complaints, returns, and non-conforming product investigations
- Providing quality training
Requirements
To be successful in this role, you should have:
- A Bachelor's degree in science or engineering
- Minimum 5 years of experience in ISO 9001 system management and QA site management
- Experience in setting up QMS systems is preferred
- Knowledge and experience in ISO 9001 quality system requirements and certification processes
- Experience working in the pharmaceutical manufacturing/biotechnology industry is preferred
- Excellent communication skills and effective bilingualism in English and Mandarin
We are an equal opportunity employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. We maintain a drug-free workplace and provide opportunities for professional growth and development.
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