质量负责人

Qualifications: • Bachelor's degree or higher in Chemistry, Pharmacy, Biochemistry or a related discipline • Licensed Pharmacist • Meet the qualification requirements for both Head of China Quality and Qualified Person under applicable China MAH regulations • Demonstrated expertise in GMP, GCP, and GLP compliance and a strong understanding of China (NMPA) and global regulatory standards (FDA, EMA, ICH). • Minimum of 5 years working in Pharmaceutical Quality Assurance with direct Quality Management Systems experience. • Previous direct experience working in pharmaceutical manufacturing or quality control. • Experience providing quality oversight of contract manufacturing organizations (CMO/CDMO) highly desirable. • Experience with QMS platforms • Previous experience as Quality Manager, Head of Quality, Quality Director, or Qualified Person is preferred. • Flexibility to work with global QA and corporate teams • Must be able to work and communicate independently

职位描述

Delilia Li