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
 

Provides functional hands-on quality supports to product complaint management at affiliate level to ensure that business and quality objectives are met.Responsible for the support of analytical techniques for products in China, including IDC testing supports etc.; responsible for the investigation of quality events happened in Gilead China, quality investigations of quality issues for imported products and products in the market according to global and local procedures.Responsible for quality-related regulatory intelligence and risk assessment.Manage GMP/GSP related records, support and manage activities related to importation, internal and external quality audits, quality agreements, routine distributor visits, product market actions, training records etc.Ensure all GMP/GSP documents (including SOPs/records in China affiliate) are maintained and revised in compliance with Gilead and local regulatory requirements.Prepare and ensure quality reports including quality analysis/trends, quality documents/records and follow up the execution of action plan, etc.Provide training support/management for all staffs at affiliate level.Follow quality principles to ensure effective compliance of the affiliate quality system with Gilead policies, processes and procedures and all applicable regulations and industry standards, including creating and maintenance of local procedures, work instructions, records and all applicable quality system documents.Participate in internal and external quality audits to support the launch and distribution of Gilead products in China.Communicate with internal and external customers on all quality and compliance-related matters.Assist the Affiliate Quality on project execution and administration, including: prepare Service/PO/Contract approval; document various aspects of the projects according to the project management procedures.  Ad-hoc tasks assigned by line manager.Occasional trips to activities needed.

Knowledge, Experience and Skills

5+ years of relevant experience in the pharmaceutical industry. 2+ years of quality experience working at GMP manufacture site.Bachelor's degree or above in pharmacy or a related field.Good communication skill, expression ability and teamwork spirit.Good English speaking and writing skills.

Able to work independently

 

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专员，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专员II，负责支持吉利德在中国的质量活动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投诉管理提供直接的质量支持，以确保达到业务和质量目标。负责中国产品分析技术的支持，包括进口检验的支持等；负责对在吉利德中国发生的质量事件进行调查，按照全球和本地程序对进口产品及进入市场的产品的质量问题进行质量调查。负责质量相关的法规情报，并进行风险评估。管理GMP/GSP相关记录，支持和管理与进口，内外部质量审计，质量协议，经销商的例行拜访，产品市场行为，培训记录等有关活动。确保所有的GMP/GSP文件（包括吉利德中国的流程/记录）的维护和更新均符合吉利德和当地法规要求。准备和确认质量报告，包括质量分析/趋势，质量文件/记录以及跟进行动计划的执行等。为吉利德中国的所有员工提供培训支持/管理。遵循质量原则，以确保吉利德中国质量体系符合吉利德政策，流程和程序以及所有适用的法规和行业标准，包括建立和维护本地流程，工作说明，记录和所有适用的质量体系文件。参与内外部的质量审计以支持吉利德产品在中国的上市和销售。与内外部客户就所有质量和合规性问题进行沟通。在项目执行和管理方面协助吉利德中国质量部，包括：服务/采购订单/合同批准；根据项目管理程序记录项目的各个方面。完成直线经理分配的临时任务。需要偶尔出差。

知识，经验和技能

5年以上制药行业工作经验，2年以上生产工厂药品质量工作经验。具备药学或相关专业本科以上学历。良好的沟通能力，表达能力和团队合作精神。良好的英文说写能力。能够独立工作。
For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.