QA Manager, Quality Assurance

Gilead

  • 上海市
  • 短期
  • 全职
  • 1个月前
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.Job Description
  • Provide routine quality support for Gilead China’s imported products and distribution to ensure that quality objectives are met and support business.
  • Collaborate with commercial team to provide support for products in-country testing.
  • Handle product complaints at local level to meet internal and external requirements.
  • Conduct quality investigations for quality events at the affiliate level such as quality discrepancy of shipments and products to the markets.
  • Follow quality principles to ensure effective compliance of the affiliate quality system with Gilead policies, processes and procedures and all applicable local regulations and industry standards, including developing and implementing of local procedures, work instructions, records and all applicable quality system documents.
  • Support the quality management system and procedures as MAHD to ensure compliance with Chinese regulatory requirements.
  • Support the drug annual report process, and report to the drug regulatory authorities as required to ensure compliance with Chinese regulatory requirements.
  • Participation in the internal and external quality audits in support of products launch in China and to the market.
  • Participation in new product launch projects and global/local project.
  • Manage training and document quality management to ensure all quality training program and quality documents in compliance with the Gilead and local regulatory requirement.
  • Perform ad-hoc tasks assigned by line manager.
  • Undertake occasional travel as needed for business activities.
Knowledge, Experience and Skills
  • 10 years of relevant experience in the pharmaceutical industry with at least 3 years in quality assurance.
  • Experience in establishing/maintaining GMP/GSP quality system.
  • A BS degree or above in pharmacy or relevant areas
  • Good communication skill, expression ability and teamwork spirit.
  • Proficiency in both spoken & written English.
在吉利德，我们致力于为所有人创造一个更健康的世界。过往逾35年间，我们在HIV、病毒性肝炎、COVID-19、肿瘤等危及生命的疾病领域持续推动药物革新，改善患者生活，并在全球范围内提升药物可及。未来，我们将继续应对全球最具挑战的健康问题，为实现这一使命，需要我们同心协力、坚定信念和不懈努力。每个你，都将在我们探索和推动改变生命的科学创新进程中扮演至关重要的角色，“吉客”是我们得以实现伟大愿景的重要伙伴，我们期待充满热忱、志存高远的你，在这里创造真正的影响力。我们深信卓越的管理者才能赋能卓越的团队，每一位吉利德领袖都致力于为“吉客”创造积极的工作体验。无论你现在、抑或有志向成为团队管理者，都是塑造“吉客文化”的关键“引擎”，让我们共同创造一个让每位“吉客”都能感受到包容、持续成长和充分赋能的职场环境，实现未来无限可能。加入吉利德科学，携手，突破不可能！吉利德科学公司目前正在招聘一名质量经理，工作地点在吉利德中国位于上海浦东的商业办公室。这个职位将作为质量经理，负责支持吉利德在中国的质量活动，负责质量管理以保证吉利德中国的产品符合吉利德总部和当地的内外部质量要求，助力中国业务的发展。
  • 在吉利德中国为产品进口和经销提供日常质量支持，以确保达到业务和质量目标。
  • 和商业团队合作对进口中国的产品提供当地药检的质量支持。
  • 支持吉利德中国产品投诉的质量管理，以符合内外部相关要求。
  • 根据吉利德总部及当地质量程序，对吉利德中国发生的质量事件的调查，例如到货产品及客户投诉的产品质量事件
  • 遵循质量原则，确保吉利德中国的质量体系有效符合吉利德政策、流程和程序以及所有适用的当地法规和行业标准，包括建立和执行本地程序、工作说明、记录和所有适用的质量体系文件
  • 支持MAH境内责任人管理体系的规章制度和流程并执行以符合法规相关要求。
  • 支持药品年度报告制度，并按照规定向药监部门报告以符合法规相关要求。
  • 参与内外部的质量审计以支持吉利德中国产品在中国的上市和销售
  • 参与包括新产品上市，总部及中国的项目
  • 管理质量培训及质量文件以确保所有质量相关培训及所有质量文件均符合吉利德总部和当地监管部门的要求。
  • 直线经理分配的临时任务
  • 需要偶尔出差
知识，经验和技能
  • 10年以上制药行业工作经验，3年以上药品质量工作经验
  • 具有建立及维护GMP/GSP质量体系的经验
  • 具备药学或相关专业本科以上学历
  • 优秀的沟通技巧，表达能力和团队合作精神
  • 良好的英文说写能力
For Current Gilead Employees and Contractors:Please apply via the Internal Career Opportunities portal in Workday.

Gilead