QA Manager

Job Location(s) CN-Shanghai | CN-Beijing
Job Number
Job Category
Quality Assurance
Position Type

Job Overview

- Perform all of the activities required to host client audits.
- Review and approve responses to audit/ inspection findings and provide guidance and support to ensure proper corrective and preventive measures are included
- Assist in the tracking of client issues identified from client audits in Veeva system
- Conduct internal training s it relates to providing clients with information during audits
- Analyze tracking and trending of issues related to client audits
- Assist with mentoring the Client Interactions new hires
- Review and approve audit responses to CAPAs
- Ensure client audit reports are completed in a timely manner
- Assist with the completion of client audit questionnaires
- Participate in the design and implementation of appropriate solutions and process improvements which enhance customer satisfaction
- Quality Assurance
-     Participate in revision of Client Interactions SOPs
-     Support development of processes and SOPs by processes   owners outside CQA


- University / College degree, BA/BS (life science preferred) or equivalent experience
- Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
- Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
- Knowledge of the drug development process from the perspective of a contract research organization
- Experience in Facilitating Client Audits


Five to eight years of experiences in pharmaceutical / CRO industries or in a medical / clinical / laboratory or other scientific role
Good analytical skill
Excellent oral, written and presentation skills
Proven interpersonal skills
Ability to function as a member of a global clinical team


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