上海招聘

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 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

Our mission is to build a preeminent biopharmaceutical organization to develop and commercialize globally innovative products in Greater China and other emerging Asia Pacific markets.

Our advantage includes an insight-driven, highly productive business development engine and world-class clinical and regulatory teams, supported by a substantial financial foundation.