Assoc Director, Quality Assurance, Shanghai

å‘表 2025-07-05
过期 2025-08-05
ID #2973292044
Free
Assoc Director, Quality Assurance, Shanghai
China, 上海, 上海,
å‘表 July 5, 2025

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Job Description

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 functional hands on supporting to the Affiliate Quality organization to ensure that quality objectives are met and support business.
  • 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
  • Establish and improve the quality management system and procedures as MAHD to ensure compliance with Chinese regulatory requirements, and represent the overseas MAH to report to the drug regulatory authorities.
  • Establish and improve the drug annual report process, and report to the drug regulatory authorities as required to ensure compliance with Chinese regulatory requirements.
  • Lead the quality compliance of product distribution at affiliate level. Take the quality contact of Gilead China to participate in HA inspection.
  • Participation in the internal and external quality audits in support of products launch in China and to the market.
  • Responsible for managing product complaints at local level. Lead the investigation of quality events at the affiliate level such as quality discrepancy of shipments and products to the markets in compliance with global and local quality procedures.
  • Responsible for working with commercial team in providing supports on in-country testing.
  • Quality representative for new product launch projects and global/local project.
  • Responsible for training and document quality management to ensure all quality training program and quality documents in compliance with the Gilead and local regulatory requirement.
  • Ad-hoc tasks assigned by line manager.
  • Occasional trips to activities needed.
  • Knowledge, Experience and Skills

  • 15+ years of relevant experience in the pharmaceutical industry. 10+ years of experience on the quality assurance.
  • Experience on establishing/maintaining GMP/GSP quality system, leading the quality investigations at the affiliate level. Quality Audit experience would be a plus.
  • A BS degree above in pharmacy or relevant areas
  • Good communication skill, expression ability and teamwork spirit.
  • Proficiency in both spoken & written English.
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  • For Current Gilead Employees and Contractors:

    Please apply via the Internal Career Opportunities portal in Workday.

    Job Title (Translated)

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    Job Description (Translated)

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    工作类型: å…¨èŒ
    åˆåŒç±»åž‹: æ°¸æ’çš„
    薪酬类型: æ¯æœˆ
    èŒä¸š: Assoc director, quality assurance

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