QA Director
方达医药技术（上海）有限公司
- 公司规模：150-500人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2013-05-14
- 工作地点：北京-通州区
- 招聘人数：1
- 工作经验：十年以上
- 学历要求：本科
- 语言要求：英语
- 职位类别：药品生产/质量管理 总监/部门经理
职位描述
JOB DESCRIPTION
Director, Quality Assurance - China Operations
Frontage Laboratories has an exciting opportunity for an experienced Director, Quality Assurance in our China location. The ideal candidate will have prior experience working in the pharmaceutical, biotech, medical device or other life science industries.
Responsibilities:
· Manage and implement the overall quality program for Frontage Laboratories (China)
· Responsible for mentoring and monitoring the quality leaders in charge of GMP CMC/CTM Manufacturing, Biological Services/GLP and Clinical Services/GCP in China
· Prepare, review and/or approve: SOPs, protocols, reports, SOPs related to Quality as needed, with coordination from our USA Quality Team
· Facilitate communication and interact with management and clients to resolve compliance issues
· Performs corporate GMP / GLP / GCP internal oversight audits
· Provides regulatory inspection support to local QA as needed
· Provides client/sponsor audit support to local QA as needed
JOB REQUIREMENTS
BS/MS in scientific discipline, regulatory affairs, or quality assurance
Minimum of ten (10) years relevant experience in pharmaceutical industry
Strong knowledge in pharmaceutical regulations and guidance for GMP, GLP, GCP
OTHER
As a member of the Frontage team, you'll find an environment that celebrates diversity and encourages the open exchange of ideas. We are proud to offer an attractive salary along with a generous benefits package designed to support the needs of you and your family while addressing work/life issues.
Director, Quality Assurance - China Operations
Frontage Laboratories has an exciting opportunity for an experienced Director, Quality Assurance in our China location. The ideal candidate will have prior experience working in the pharmaceutical, biotech, medical device or other life science industries.
Responsibilities:
· Manage and implement the overall quality program for Frontage Laboratories (China)
· Responsible for mentoring and monitoring the quality leaders in charge of GMP CMC/CTM Manufacturing, Biological Services/GLP and Clinical Services/GCP in China
· Prepare, review and/or approve: SOPs, protocols, reports, SOPs related to Quality as needed, with coordination from our USA Quality Team
· Facilitate communication and interact with management and clients to resolve compliance issues
· Performs corporate GMP / GLP / GCP internal oversight audits
· Provides regulatory inspection support to local QA as needed
· Provides client/sponsor audit support to local QA as needed
JOB REQUIREMENTS
BS/MS in scientific discipline, regulatory affairs, or quality assurance
Minimum of ten (10) years relevant experience in pharmaceutical industry
Strong knowledge in pharmaceutical regulations and guidance for GMP, GLP, GCP
OTHER
As a member of the Frontage team, you'll find an environment that celebrates diversity and encourages the open exchange of ideas. We are proud to offer an attractive salary along with a generous benefits package designed to support the needs of you and your family while addressing work/life issues.
公司介绍
方达医药全球型全方位新药研发外包服务公司（CRO）,于2001年成立于美国，总部位于宾夕法尼亚州费城西郊的埃克斯顿。2006年成立方达医药技术（上海）有限公司，在苏州和郑州分别设有分公司和管理团队。2019年5月30日，方达控股（方达医药上市主体）成功登陆香港联交所主板，股票代码*******。
方达医药始终坚持“中美两国，同一质量体系”准则，获得数据可用于全球申报，目前已为全球400多家客户提供高质量、高标准的新药和仿制药研发服务。作为中国制药企业国际化及高端药物研发合作伙伴，方达医药拥有技术熟练的专业团队，配备了国际最先进的药物研发仪器和设备，并努力为客户创造友好轻松的合作和沟通环境。专注于一体化的专业服务，业务范围包括生物分析、BE临床服务、CMC药品制剂研发、cGMP咨询及国际药品注册等服务项目。
● 我们为员工提供全面的福利待遇，并履行对员工健康和福利的全面承诺。
● 我们为员工提供了与***制药公司合作的机会，让其成为药物开发过程的关键贡献者。
● 我们为员工提供良好的职业发展机会，确保员工在行业内不断积累经验。
● 我们的员工是最有价值的资产，我们拥有明确的员工奖赏计划，肯定员工的奉献精神，奖励员工的辛勤付出。
您也可以发送简历至招聘邮箱：recruitment@frontagelab.com.cn
更多信息请浏览公司网站：**********************
方达医药始终坚持“中美两国，同一质量体系”准则，获得数据可用于全球申报，目前已为全球400多家客户提供高质量、高标准的新药和仿制药研发服务。作为中国制药企业国际化及高端药物研发合作伙伴，方达医药拥有技术熟练的专业团队，配备了国际最先进的药物研发仪器和设备，并努力为客户创造友好轻松的合作和沟通环境。专注于一体化的专业服务，业务范围包括生物分析、BE临床服务、CMC药品制剂研发、cGMP咨询及国际药品注册等服务项目。
● 我们为员工提供全面的福利待遇，并履行对员工健康和福利的全面承诺。
● 我们为员工提供了与***制药公司合作的机会，让其成为药物开发过程的关键贡献者。
● 我们为员工提供良好的职业发展机会，确保员工在行业内不断积累经验。
● 我们的员工是最有价值的资产，我们拥有明确的员工奖赏计划，肯定员工的奉献精神，奖励员工的辛勤付出。
您也可以发送简历至招聘邮箱：recruitment@frontagelab.com.cn
更多信息请浏览公司网站：**********************
联系方式
- Email：recruitment@frontagelab.com.cn
- 公司地址：地址：spanhomebase