Compliance Manager

• Regulatory and AZ policy & standards

• Catch up and review the current regulatory requirements and make assessment to Taizhou site, including:

• GMP or guidelines

  Q&C Manual

• Prepare, review/approve the documentation to regulatory authorities, and ensure license to operate
• Develop compliance improvement plan and monitor the its implementation
• Ensure GMP compliance during the planning, execution and closeout phases of projects.

• Quality systems management

• Create and maintain document system
• Manage the change control systemDevelop GXP training system and ensure its implementation
• Maintain custom complaint and suspect sample management system and ensure its implementation
• Maintain the lifecycle management system of computerize system and ensure its implementation
• Establish and maintain data integrity management system
• Maintain management review system and ensure its implementation
• Monitor quality metrics
• Maintain IMT and recall management system
• Maintain site CIP management

• Supervisory responsibilities

• Lead daily job in compliance department
• Inspire, educate and develop the subordinators to achieve department targets
• Build and develop team capability
• Conduct formal performance evaluations to staff

• GMP requirements

• Establish and maintain quality management system based on GMP requirements
• Supervise effective execution of GMP
• Provide GMP support, suggestion and training to other functions

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.