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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 strategic leadership and oversight for Great China daily operations, including quality oversight, process compliance, and risk management.
- Oversee nonconforming material control, quality investigations, material disposition, and end-to-end CAPA processes.
- Monitor, analyze, and report distribution and operational quality metrics; identify gaps and drive continuous improvement initiatives.
- Lead the development, review, approval, and maintenance of regional Quality System documents including SOPs, forms, specifications, and validation documents.
- Ensure complete, accurate, and timely management of quality records and compliant record retention practices.
- Support process verification and validation activities; review and approve changes, deviations, and exceptions to mitigate quality risks.
- Collaborate closely with Global Quality to align regional strategies and execute key initiatives including change management, complaints, recalls, audits, inspections, supplier quality, and quality management reviews (QMR).
- Partner with Regulatory Affairs to support GC product registration, satisfy onsite audit, quality inspections, and ongoing regulatory compliance in Great China.
- Work with Commercial and Legal teams to integrate quality requirements into contracts, channel management, field actions and reporting, recall management, PRAR reports, and customer/supplier quality agreements.
- Oversee quality training programs for customer-facing and operational teams across Great China.
- Develop and implement regional Quality & Regulatory strategic plans to support Illumina’s long-term growth in the China NGS market.
- Represent Quality function in making quality strategies and making decisions on quality directions in supporting commercial growth plan.
- Perform other duties as assigned by senior management to support quality and business objectives in Great China.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Preferred Requirements:
- Experience in NMPA quality requirements for both local and foreign imported medical devices (class I-III)
- Experience in ISO 13485 quality management
- Experience in multinational companies’ quality function and performed quality management duties
- Experience working in a global company with overseas headquarters in establishing manufacturing and operations in China
- Minimum of 10~15 years of quality management experience in a complex, diagnostic manufacturing environment
- Broad experience working in China with a proven start-up track record of success
- Experience working in a highly matrix and collaborative environment
- Self-starter with the ability to deal with ambiguity
- Fluent in English and Mandarin
- Able to think strategically and provide hands-on support
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Preferred Experience/Education:
- Requires Bachelor's degree or equivalent, may require an advanced degree (Master's), in applicable field or equivalent.
- Typically has 10+ years of applicable management experience as assessed by Illumina Executive Staff
- Broad knowledge of all areas within particular Corporate sub-function or a function within an operation.
- Typically has depth of technical knowledge in function derived from experience in non-management and middle management roles.
- More than 10+ years of experience leading and managing cross functionally and managing matrix teams
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
