Illumina

Genomic Technology

Sr.QualityManager

China FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

Genomic Technology
Problems you'll solve

risk management; identify gaps

Eligibility Requirements

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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