Senior Manager, Quality Assurance
CN · Shanghai · China, Shanghai · Hybrid in China · Full-time · Senior
Salary not stated
AI summary
About the company
ICON是全球最大的合同研究组织（CRO），拥有超90个赞助伙伴，业务覆盖全球，致力于开发惠及患者的治疗方案。
Role overview
该岗位为ICON在上海的全职混合办公岗位，负责临床研究的质量保证与合规管理，需带领团队制定QA策略、开展合规审计、处理质量问题并指导团队，工作成果将助力全球患者受益的治疗方案开发。
Responsibilities
- 制定并实施质量保证策略与流程，支持临床试验活动
- 开展全面质量评估与审计，确保符合监管标准
- 跨团队协作识别并解决质量问题，落实整改措施
- 审核临床试验文档与数据，确保准确完整
- 领导并指导QA团队，打造卓越与持续改进的文化
Requirements
- 相关专业学士学位
- 7年以上制药/生物/CRO行业QA经验，含至少3年管理经验
- 熟悉ICH-GCP、FDA等临床试验监管要求
- 具备出色的分析与解决复杂质量问题的能力
- 优秀的沟通与人际协作能力
- 具备岗位所在地合法工作权
- 可接受约35%的出差
Pay & benefits
- 有竞争力的基本工资与绩效奖金
- 医疗、牙科、视力等健康福利
- 退休与养老金计划
- 人寿与伤残保险
- 员工援助计划
- 结构化培训与职业发展机会
Notes for China-based candidates
- 需具备中国合法工作权
- 可接受约35%的出差
- 混合办公（办公室或居家）
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Excerpt
Senior Manager, Quality Assurance At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where…
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