Quality Assurance Manager

6 days ago


Singapore GenScript Full time

About GenScript

GenScript is a leading global biotechnology group with a strong presence in North America, Europe, the Greater China, and Asia Pacific. Founded in 2002, our company has established itself as a trusted partner in the life science industry.

We offer a comprehensive range of services, including gene synthesis, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy. Our commitment to innovation and quality has earned us a reputation as one of the most reliable biotech companies in the world.

About ProBio

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.

Job Description

The Head of Quality promotes the construction and optimization of GenScript's (Singapore) Quality System, ensuring its continued effectiveness. 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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