Vice President of Global Quality
Vice President of Global Quality
Posted on :
03-08-2025
Employer Active
1 Vacancy
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Monthly Salary
$ 273400 - 410000
Vacancy
1 Vacancy
Posted on :
03-08-2025
Job Description
What if the work you did every day could impact the lives of people you know Or all of humanityAt 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.
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 To learn more visit: 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.
Position Summary
Illumina is seeking a strategic hands-on and transformational Vice President of Global Quality to lead and evolve the quality function across our global enterprise. This leader will oversee the entire function globally including Design Quality Quality Assurance Quality Systems Supplier Quality Quality Compliance and Software Quality initiatives across manufacturing sites distribution centers research & development and corporate headquarters. The ideal candidate will bring a proven ability to build high-performing teams foster a quality-driven culture drive change management and ensure robust compliance with global regulatory standards including FDA ISO 13485 EU MDR and other international requirements. The position is based in San Diego CA.
Key Responsibilities
- Develop and execute Illuminas quality vision and strategy aligned with company goals and evolving regulatory landscapes.
- Lead the Quality Assurance Quality Systems Supplier Quality Design Quality Software Quality Quality Compliance and Risk Management teams across all global sites.
- Ensure compliance with domestic and international regulatory standards including FDA 21 CFR Part 820 ISO 13485 ISO 14971 EU MDR MDSAP and other applicable requirements.
- Oversee the Quality Management System (QMS) ensuring it is scalable harmonized and digitally optimized to support company growth and both RUO and IVD products.
- Lead preparation for regulatory inspections and audits (FDA Notified Bodies Ministries of Health) manage responses to findings and drive timely resolution and continuous improvement in collaboration with the business.
- Lead supplier quality programs including auditing incoming inspection and performance monitoring aligned with risk-based approaches and best practices
- Provide independent quality oversight for global analytical labs and partner with contract manufacturers and external suppliers to ensure product quality and supplier compliance.
- Oversee quality functions in product development design controls verification & validation (V&V) complaint handling CAPA risk management and post-market surveillance.
- Drive digital transformation initiatives including the validation and utilization of QMS platforms and data integrity systems and explore the use of AI to enhance quality processes.
- Develop and track quality metrics and KPIs to proactively identify trends risks and opportunities for continuous improvement.
- Cultivate a proactive quality culture through cross-functional collaboration training programs and internal communication strategies.
- Manage departmental budgets and ensure resource allocation aligns with corporate priorities.
- Act as a key quality and regulatory liaison with customers regulatory bodies and external partners.
Qualifications
- Bachelors degree in Engineering Life Sciences or a related technical field required; Masters degree preferred.
- 20 years of progressive quality leadership experience in medical device pharmaceutical or combination product industries.
- Extensive knowledge of global regulatory standards including FDA ISO 13485 ISO 14971 EU MDR MDSAP and applicable IEC standards.
- Proven track record in leading FDA and international regulatory inspections and implementing corrective/preventive actions.
- Strong experience with design controls V&V post-market risk management and the full product lifecycle.
- Expertise in digital quality systems computer system validation data integrity product cybersecurity and QMS platforms.
- Demonstrated success in managing large cross-functional global teams including direct oversight of quality regulatory engineering and purchasing control functions.
- Exceptional leadership strategic thinking negotiation and cross-functional collaboration skills.
- Certified Quality Auditor (CQA) Certified Quality Engineer (CQE) Certified Quality Manager (CQM) or Regulatory Affairs Certification (RAC) preferred.
- Hands-on experience in designing and executing a large-scale organization transformation a plus.
- Ability to travel within and outside the United States of America (approximately 10%30% depending on business needs).
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 To learn more visit: 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.
Required Experience:
Chief
Employment Type
Full-Time
Key Skills
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