Vice President of Global Quality

Vice President Of Global Quality

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 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