Summary of Position

The Quality Assurance Manager – R&D ensures that all research, development, and validation activities are conducted in full compliance with company quality standards, applicable regulations, and international guidelines. This role leads the implementation and continuous improvement of quality processes within the R&D department, fostering a strong culture of quality and compliance. The role oversees quality aspects related to investigational medicinal products (IMPs), including manufacturing, packaging, labelling, storage, and distribution, as well as pharmacovigilance activities associated with clinical research.

Essential Functions

-Develop, implement, and maintain the quality management system applicable to R&D activities (SOPs, work instructions, standards, etc.).

-Ensure compliance of R&D projects assigned to CMO Office with relevant regulations (e.g., GCP, GVP, GMP, GLP, ISO, ICH, or other i...