Illumina
Genomic Technology
Sr.QualityManager
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“Sr. Quality Manager at Illumina. Skills: Quality Management, Regulatory Compliance, Quality System. Lead Quality function in Great China. ensure compliance with quality policies”
What You'll Achieve.
measure, monitor and drive continuous improvement; meet ongoing operational and compliance objectives; support the company’s China NGS market expansion objectives; support Illumina’s long-term growth in the China NGS market
Industry & Context.
risk management; identify gaps
not eligible for visa sponsorship
What They're Looking For.
Must Have
NMPA quality requirements, ISO 13485 quality management, multinational companies’ quality function, global company with overseas headquarters, quality management experience, working in China, highly matrix and collaborative environment, Fluent in English and Mandarin, think strategically, provide hands-on support
Nice to Have
advanced degree (Master's), depth of technical knowledge, leading and managing cross functionally, managing matrix teams
What You'll Do.
Lead Quality function in Great China
ensure compliance with quality policies
drive quality excellence
support China NGS market expansion
Lead Operations QA organization
ensure robust quality governance
Ensure full compliance with regulations
Provide strategic leadership
oversee daily operations
Oversee nonconforming material control
Monitor distribution and operational quality
drive continuous improvement
Lead development of Quality System documents
Ensure management of quality records
Support process verification and validation
Collaborate with Global Quality
Partner with Regulatory Affairs
Work with Commercial and Legal teams
Oversee quality training programs
Develop and implement strategic plans
Represent Quality function
making quality strategies
making decisions on quality directions
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Collaborate closely with Global Quality; Partner with Regulatory Affairs; Work with Commercial and Legal teams; managing matrix teams
Communication Scope
Fluent in English and Mandarin
Full Job Description
What if the work you did every day could impact the lives of people you know? Or all of humanity? ## At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. ## Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. ## **Position Summary:** This position is responsible for quality activities that measure, monitor and drive continuous improvement of Illumina’s compliance with Quality System Regulations, Illumina Quality Policies, NMPA and relevant markets regulations and ISO quality standards. The role also oversees product quality for both commercial and manufacturing organizations to meet ongoing operational and compliance objectives. **Responsibilities:** As the Great China Quality Head, you are accountable for leading the entire Quality function in Great China (Mainland, Taiwan, Hong Kong etc.), ensuring compliance with global and local quality policies and regulations including but not limited to Illumina’s quality standards, and driving quality excellence to support the company’s China NGS market expansion (RUO and Clinical) objectives. Responsibilities include: * Lead and manage the overall Quality organization in Great China region including Operations QA, to ensure robust quality governance across product development stages, product manufacturing, assembly, and related operational activities. * Ensure full compliance with China GMP, QSR, ISO 13845, GDP, GCPand other applicable regulatory requirements across distribution warehouses, commercial site, and operational sites. * Provide strateg
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