• 招聘类型：社招
• 工作性质：全职
• 所属区域：北京 - 昌平
• 直属部门：Chemistry

职位描述

• Responsible for management of Quality System to ensure compliance with company standards, cGMP, regulatory requirements, applicable where clinical trials are conducted, or for the markets where products are sold. This includes CFDA, USFDA, and other relevant competent authorities in EU as well as applicable international quality standards
• Partner with the leaders and team members of BeiGene Global Quality organization to establish quality practices that are clear and efficient and consistent globally
• 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
• Responsible for conducting the Annual Product Review
• Implement a quality training system including monitoring effectiveness
• Provide leadership, guidance and development opportunities for direct reports
• Other duties as assigned

任职条件

• Minimum of 10 years of experience in GMP QA environment with @least 7 years QA management experience in manufacturing biological and small molecule products
• Capability of controlling and completing multiple issues with a clear sense of priority
• Demonstrated experience in leading and driving high performing teams
• Experience with distribution of commercial pharmaceutical product is a plus
• Prior experience working in a multi-national of global company is strongly desired
• Ability to critically analyze and resolve issues
• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
• Superior interpersonal communication skills to succeed in partnering cross-functionally within BeiGene quality groups and across BeiGene global business groups

职位要求

• 学历要求：本科及以上
• 工作经验：10年
• 外语要求：English