Qualified Person CN, Director Chinese Distribution center
Parexel International Corporation
Shanghai, Shanghai Municipality, China
Director Chinese Distribution Center (CNDC)
Job Title Qualified Person CN, Director Chinese Distribution Center (CNDC)
Department Clinical Trial Supply & Logistics
Reports To Leading Qualified Person, Senior Director European Distribution Center, CTS&L Global Quality Head
Directly Supervises Heads of Quality Control and Quality Specialists at CNDC in China; in alignment with all Leading Qualified Person at CNDC
Provides Work Direction to Depot, Production & CLS: Packaging, Labeling & Distribution (PLD), Quality Management, CLS, PM&D
Works Closely with Packaging, Labeling & Distribution (PLD), Quality Management System, Regulatory, Pharmacovigilance, Quality Assurance, Clinical, Risk Management, Human Resources, Procurement, Facilities, Legal, and Responsible Pharmacists.
External Relationships CMO, Sponsors, Local Health Authorities, State Authorities, Regulatory Authorities, external manufacturer, laboratories suppliers and other third-party vendors
Billable Job ☒ Yes ☐ No
Select One ☐ Individual Contributor ☒ People Manager
As required by the Drug Administration Law of the People's Republic of China, Chinese GMP guidelines and/ or Parexel needs, all Medicinal Products and Investigational Medicinal Products (IMPs) must be certified by a Qualified Person (QP) prior to release for use in a Clinical Trial.
• Chinese fluent (written and oral)
• English fluent (written and oral)
Knowledge and Experience:
• Experience with PDA, TR, ISPE, PIC/S and ICH etc.
• Experience with CFDA GMP, EU GMP, FDA and cGMP.
• Experience with CN QP certification and release of medicinal products and IMP
• Experience with Import & Export of pharmaceutical products
• Experience in Quality Control, Quality Assurance, Quality Systems, Quality Compliance and Quality Improvement required
• GMP / GCP auditing experience
• Regulatory Inspection experience
• Managerial Experience
• Experience in Line Management of international teams
• Six Sigma LEAN Green Belt or above
• Leadership/Project Management/Technology/Business Operations experience, as appropriate, required
• Fulfilment of qualification as per Drug Administration Law of the People's Republic of China (as interpreted by local Chinese authority in Suzhou China)
• University degree, major in pharmaceutical, chemistry, biology or equivalent related subjects that allows to be Qualified Person according to Drug Administration Law of the People's Republic of China
• Practical experience over a period of at least ten years, in one or more companies authorized to manufacture medicinal products in China, covering qualitative and quantitative analysis of medicinal products
• PhD degree preferred