上海招聘

 Primary Purpose of Job (Job Summary)主要工作目标（岗位简介）

·                  Perform evaluation and audits of Partners, CMOs, CROs, and Suppliers, according to JW Quality Management Quality Audit Program.

·         Strive to meet company and department goals

·         Participate in improvement projects and initiatives

·         Support Quality oversight activities

               Technical Duties/Responsibilities: ·         

 Lead and / or participate in supplier audit program. 

Responsibility includes, performing audits, writing finding letters and audit reports per established timelines, managing supplier qualification program, updating list of approved suppliers ·         

 Interact directly with suppliers, internal customers, and subject matter experts to ensure thorough evaluation and accuracy of related deviations and investigation ·         

 Communicate with suppliers and internal customers, and subject matter experts to support the evaluation of vendor change notifications, impact and action ·       

  Inform management of quality and compliance issues and provide timely impact assessments of potentially affected materials or services. ·         

 Establish, review and update Quality Agreements with suppliers ·        

 Coordinate supplier/material Risk Assessments  

 Job Duties/Responsibilities: ·        

 Follow company policies and procedures. ·         

 Set personal performance goals and provide input to departmental objectives. ·         

 Establish work priorities to meet targets and timelines. ·         

 Independently manage competing priorities with limited instruction. ·         

 Apply advanced theory, technical principles, expert judgment and cross-functional expertise to independently address a broad range of difficult problems. ·         

 Serve as a technical subject matter expert (SME) in support of department functions. ·         

 Collaborate and author department policies and procedures ·         

 Sign documents for activities as authorized and described by JW policies, procedures and job descriptions ·         Perform any other tasks as requested by Management to support Quality oversight activities     

Education/Qualifications 教育程度/所获资格证书

• B.E. or B.S. degree (preferably in biology or biological engineering) with at least 8 years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience
• Working knowledge of cGMP, GLP, GCP, FDA Guidelines and standards routinely used in the industry (Q7, ISO, IPEC, etc.)
• Detailed knowledge of manufacturing processes, laboratory test methods to include EP, USP, JP requirements, validation programs and industry standards desired
• Experience or knowledge in medical device and packaging material industries is a plus.

药明巨诺是一家专注于细胞免疫治疗、处于临床阶段的创新型生物科技公司，站在巨人的肩膀上，充分结合了美国巨诺公司国际领先的技术优势以及药明康德集团强大的本土经验。

定位与愿景：
致力于以创新为先导，成为细胞免疫治疗引领者
 - 对患者：用最前沿的细胞免疫治疗技术、高品质的产品，造福中国及全球患者
 - 对行业：与国内外合作伙伴携手开展多方位合作，共建中国细胞免疫治疗的行业规范与生态系统，打造国际领先的细胞免疫治疗技术创新平台