JobResponsibilities ? Establish/assist in the establishment of a Compliance Department capable of supporting global manufacturing operations within JHL Biotech, Inc., its joint ventures, and partnerships Implement a global Quality Management Process/System (Deviation, Investigation, and CAPA). Aid in the design and implementation of Quality Systems to support Provide QA input on GMP facility issues: Author/Contribute to QA sections of Annual Progress Reports and Annual Product .Job Requirements:
? BS degree (MS preferred), scientific discipline preferred.
? At least 10 years’ experience in QA for a regulated industry, pharmaceutical or medical device experience preferred. Minimum 5 years in management. Ability and experience in development and leadership of staff.
? Thorough, in-depth knowledge of GMPs and related regulatory guidelines. Strong prioritization and organization skills. Excellent (English & Mandarin) verbal and written communication skills.
岗位描述：
1.建立或协立质量管理部门能够支持在JHL与全球制造企业的合作关系；
2.负责全球质量管理系统(偏差,调查,和CAPA);
3.帮助设计和实施质量系统的维护；
4.提供QA在GMP设备上的问题为QA的年度产品进展报告；
任职要求：
1.本科及以上学历；
2.10年以上在质量监管、制药或医疗器械及相关行业工作经验，并有5年以上管理经验；
3.深入全面了解GMP及相关监管规定，有良好的英语表达能力。