Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
The Lead QA Specialist for Cytiva is responsible for China localization project quality related support and manage Medical Device GSP related affairs.
This position is part of the Cytiva China QA/RA located in Shanghai and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
In this role, you will have the opportunity to:
61 Quality related support China localization project: CCMD Lab etc.
61 Manage Cytiva medical device GSP related affairs.
61 Drive site quality management improvement using DBS or other quality tools.
61 Lead or contribute to post-market QA activities, external/internal audit with the purpose of driving continuous improvement, like CAPAs on time delivery and maintain QMS etc.
61 Provide/review QAA to commercial teams and customers on a timely manner.
61 All other duties as assigned by manager
The essential requirements of the job include:
61 Bachelor’s degree or above in Lifesciences (biomedical, chemistry, pharma…) relevant.
61 +5 years’ experience of quality assurance and quality management system. Familiar with GMP and/or ISO9001/13485 system and other pharma/medical device related quality system requirements.
61 Strong skills of problems solving, familiar with PSP or 6-sigma tools etc.
61 Have strong judgment, organizational coordination, communication skills and strong sense of responsibility.
61 Be able to fluently communicate in English.
It would be a plus if you also possess previous experience in:
61 Qualified the Internal auditor of ISO9001 or other pharma/medical device related quality system
61 Fast learner with good cross functional leadership capabilities