南京招聘

Provides strategic and operational leadership for the development and implementation of a consistent quality system in Good Laboratory Practice (GLP) Laboratories in Shanghai, China. Ensures compliance with local and international GLP regulations. Supports the development of a high performing team of QA associates.

在中国上海GLP实验室中，为制定和实施一致的质量体系提供战略和业务领导，确保符合当地和国际GLP法规。支持QA团队的高效发展。

Responsibilities: 职责

• Work with the lead QA management to define the strategy for quality management in GLP Laboratories including continuous process improvement and quality training.
• 与质量保证部主负责人合作，制定GLP实验室的质量管理策略，包括持续的过程改进和质量培训。
• Participate in the expansion of GLP principles and international quality standards (e.g. GCP) to other laboratory areas in WuXi AppTec Co., Ltd. as requested.
• 根据要求，参与GLP原则和国际标准 (如GCP) 在药明康德其他实验室领域的推广。
• Participate in communication with all levels of laboratory personnel and line management on purpose, direction, and goals of quality management.
• 参与与各级实验室人员和汇报线管理人员就质量管理的目的、方向和目标进行沟通。
• Review and approve QA regulatory documents when required.
• 必要时审核和批准QA法规文件。
• Conduct and report QA activities in support of BU regulatory activities, i.e., study inspections/audits, vendor audits, and facility inspections.
• 实施和报告QA活动以支持业务部门的监管活动，即，研究审查/审核，供应商审查和设施审查。
• Assure regulatory authority inspections are fully supported.
• 确保监管机构的检查得到充分支持。
• Provide input to GLP QA SOPs, and BU Operational SOPs.
• 为GLP QA SOP和业务部门运营SOP提供意见。
• Ensure consistent inspection practices of GLP QA operations within China.
• 确保GLP QA在中国区的运营遵守一致的审计程序。
• Assume the responsibilities and role of this position’s supervisor when delegated.
• 在被授权时，承担该岗位上级领导的职责和角色。
• Monitor local projects so that work is on course to meet regulatory or client submission dates.
• 监控本地项目，确保工作正常进行，以满足监管或客户提交日期的要求。
• Oversee local QA work prioritization and resource management.
• 监督本地QA工作的优先级和资源管理。
• Provide local QA groups with general direction and guidance.
• 为本地QA团队提供总体方向和指导。

Qualifications: 资质

• Degree in Science or related experience.
• 理工科或相关经验。
• At least 5 years experience in the quality assurance monitoring of Bioanalytical (LC-MS/MS and ELISA) in research & development and production environments.
• 至少5年研发和生产环境中生物分析(LC-MS/MS和ELISA)质量保证监控经验。
• Understanding of Quality systems and global regulatory (GLP) requirements.
• 理解质量体系和全球监管(GLP)要求。
• Strong communication and negotiation skills.
• 较强的沟通和谈判技巧。
• Excellent interpersonal and leadership skills.
• 优秀的人际关系和领导能力。
• Excellent communication, both written and oral, in English and Mandarin.
• 优秀的中英文书面和口头沟通能力。

Preferred:技能

• Good English skills.
• 良好的英语能力。
• Proactive compliance philosophy.
• 主动合规理念。
• Organization skills.
• 具备组织能力。
• Significant prior experience in GLP QA.
• 丰富的GLP QA经验。
  

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