QA Manager, China

Job Details

Job Type
Anissa Low
about 1 year ago
This position is responsible for supporting Regional Senior Quality Manager (Clinical Reach) in the implementation of the Quality Management System, Compliance and Continual Improvement activities for the Clinical Trial Material (CTM) Logistics operations throughout the Asia Pacific region. 
  • Responsible for China Quality Management System (QMS) compliance and management of all company-wide, quality policies, procedures, processes, programs, and practices, to assure the company of continuous conformance with appropriate regulation in China, and local or international standards to ISO 9001:2008, Good Supply/Distribution Practices (GSDP), Good Manufacturing Practices (GMP) and applicable GxP
  • Responsible for implementation of the Quality Management System, compliance and continual improvement activities for the Clinical Trial Material (CTM) Logistics operations in China.  This includes supporting/conducting on behalf of the Specialty Services Group (SSG) internal and external audits for compliance of Depot operations with global regulatory standards GxP, setup Supplier Quality Management System, set-up and improvement on Supplier Qualification Management and conduct audit/qualification of Suppliers
  • Lead inspection readiness programs and sponsor regulatory agency inspections
  • Develop and ensure effective maintenance of document quality management systems
  • Target evaluation and early detection of risk and compliance issues, identifies remedial actions and communicates issues to senior management
  • A degree in science or equivalent
  • Minimum of 5 years of industry experience and 3 years of QA experience, experience with CTM and advantage
  • Proficient in QA procedures and familiar with relevant GMP, GSP/ GDP, ICH GCP and, preferably, GLP and ISO standards. Knowledge of international regulations an advantage
  • Auditing skills and excellent documentation practices to accurately identify and communicate compliance issues discovered during the audit process
  • Previous supervisory/management experience an advantage
  • Effective written/oral communication (with excellent presentation and training skills), interpersonal skills, facilitation, and influencing skills for positive internal and external audit outcomes.
  • Proficient computer skills in MS Office applications and Internet research
  • Ability and willingness to travel (international and domestic)

License no. 17C8975