Illumina
Overview
Illumina is seeking a strategic, hands-on, and transformational Vice President of Global Quality to lead and evolve the quality function across the 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 Illumina’s 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
Bachelor’s degree in Engineering, Life Sciences, or a related technical field required; Master’s 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).
Compensation and Benefits The estimated base salary range for the Vice President of Global Quality role based in the United States of America is: $273,400 - $410,000. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
Equal Opportunity and Background Checks Illumina is an equal opportunity employer committed to providing employment opportunities regardless of sex, race, creed, color, religion, national origin, age, disability, or 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 shall be 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.
Posting and visa status 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.
Seniority level Not Applicable
Employment type Full-time
Job function Quality Assurance
Industries Biotechnology Research, Research Services, and Medical Equipment Manufacturing
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Illumina is seeking a strategic, hands-on, and transformational Vice President of Global Quality to lead and evolve the quality function across the 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 Illumina’s 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
Bachelor’s degree in Engineering, Life Sciences, or a related technical field required; Master’s 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).
Compensation and Benefits The estimated base salary range for the Vice President of Global Quality role based in the United States of America is: $273,400 - $410,000. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
Equal Opportunity and Background Checks Illumina is an equal opportunity employer committed to providing employment opportunities regardless of sex, race, creed, color, religion, national origin, age, disability, or 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 shall be 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.
Posting and visa status 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.
Seniority level Not Applicable
Employment type Full-time
Job function Quality Assurance
Industries Biotechnology Research, Research Services, and Medical Equipment Manufacturing
#J-18808-Ljbffr