职位描述：
job description:
• responsible for management of quality system to ensure compliance with company standards, cgmp, regulatory requirements, applicable where clinical trials are conducted.this includes cfda, usfda, and other relevant competent authorities in eu as well as applicable international quality standards
• interface with cfda and other regulatory agencies during site inspections; responsible for ensuring timely execution of corrective actions
• responsible for ensuring manufacturing site is inspection ready
• responsible for the release (or rejection) of api, drug product (commercial and clinical)
• partner with cmc and manufacturing team to establish consistent processes ensuring quality standards and gmp compliance
• responsible for approving procedures, analytical methods, product specifications, master batch records, raw material and api specifications, validation documents, reports for process, cleaning, equipment, analytical methods, shipping, and computerized system
• responsible for product quality control and oversight for distribution of partner’s marketed products; ensuring compliance with quality agreement
• maintain a culture of quality in line with global business strategy
• establish key performance indicators (kpi) for the quality system
• provide periodic reporting on the performance of the quality system which include metrics, performance monitoring and action plans
• implement a quality training system including monitoring effectiveness
• provide leadership, guidance and development opportunities for direct reports
• other duties as assigned
requirements:
master degree or above with fluent english;
•good working knowledge of the china regulatory framework and how that applies to pharmaceutical a product development
•developed network amongst china regulators and other key associations and organizations.
•knowledge of regulatory texts, legal texts and good experience of regulatory affairs.
•up-to-date knowledge of relevant pharmaceutical legislation and gxp;
•strong analyticl, communication, decision-making and leadership skills for interaction with external and internal customers and partners