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SM QA Operation

Job Title: SM QA Operation
Contract Type: Permanent
Location: Shanghai, China
Industry:
Salary: Negotiable
Reference: 20200813_1592818337
Contact Name: Cherry Zhu
Contact Email: czhu@profileasia.com
Job Published: June 22, 2020 17:32

Job Description

Position Title:

SM QA Operation

Department:

Quality Assurance

Report To:

QA AD

Location:

Beijing/Shanghai

Position Summary

Responsible to achieve high level of quality and compliance, by effectively managing GxP vendors, analyzing and reporting quality metrics. Assisting coordination and management of inspection for vendors of Everest. Support investigations of Scientific Misconduct and Serious GxP Non-Compliance and the handling CAPA management, as required and assigned by QA Management.

Key Responsibilities

  • Develop process and establish system for managing GxP vendors.
  • Develop and maintain up to date quality agreement, incorporated with the service master agreement.
  • Perform vendor due diligence activities, maintain preferred vendor list for GxP service.
  • In collaboration with Everest functions, ensure the key performance indicator and key quality indicator is developed and monitored, issue is reported and followed with appropriate actions
  • Assure that appropriate metrics are generated, monitored and reported to enable continuous performance improvements for the department and assist the business in making informed decisions.
  • Analyze trending based on the data of quality metrics.
  • Conduct and document new hire on-boarding GCP training, ongoing Clinical Development GCP training periodically.
  • Maintain the master training matrix for quality function.

 

Recommended Education and Key Competency

  • Minimum of bachelor's degree or equivalent in scientific or life science discipline.
  • At least 10 years of experience in clinical research and development
  • At least 5 years of experience in quality management and 2 years of experience of vendor management
  • Track record of establishing effective business relationships with internal and external customers
  • Excellent leadership skills including the ability to prioritize critical needs, act decisively and handle a high volume of complex tasks within a given timeframe
  • Excellent written and verbal communication skills
  • Excellent project management, communication, management and organizational skills, as well as a high level of proficiency with problem-solving, conflict resolution, negotiation and team-building skills
  • Excellent written and verbal communication skills

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