Establish and Maintain the Quality Management System
·Develop Clinical Development quality manual, with determine quality framwork for governing overall quality of Clinical Development, ensure to integrate the quality objective into the orginzation's business goals and processes.
·Lead Risk Management and compliance activities. Develop and implement processes for quality risk identification, assessment, control, review, tracking, communication, resolution and escalation as applicable.
·Creat Quality metrics and prepare for Management review.
·Develop quality plan, define the quality objective, prioritize the resource to manage the quality issues.
·At least 5 years of experience maintaining quality systems and 10 years working in the clinical development industury.
·Experience in writing and maintaining design and document control processes.
·Experience in writing and implementing quality procedures.
·Expert Knowledge and understanding of GxP, risk management, issue management, regulatory standards in pharmaceutical industry, including requirements and expectations of global regulatory bodies. Participation in regulatory audits.
·Excellent leadership skills including ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe.
·Languages: Strong command of English.
·At least bachelor's degree in Science, Healthcare or an equivalent.Master degree is preferred.
Contact Person：Frank Wang