QA Manager, Quality Assurance
QA Manager, Quality Assurance
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Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads 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 were 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 Chinas 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.
35HIVCOVID-19
- MAH
- 103
- GMP/GSP
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Manager
Employment Type
Full-Time
