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Illumina

Develops sequencing platforms and consumables

Senior Manager - Design Quality

Regulatory & Quality (Life Sciences)Updated on Nov 13
Full-timeSan Diego, CA, USAIn-person

About the Job

Requirements

  • A bachelor's degree is required.
  • A minimum of 12 years of related experience is required.
  • Three to six years of management experience is required.

Responsibilities

  • Provide coaching, technical guidance, independent Quality challenge, document review and approval, and timely resolution of complex product and Quality issues while supporting product-development programs.
  • Establish fit-for-purpose Quality strategies and enable execution across product-development programs, including design planning, requirements, design reviews, verification and validation, design transfer, process validation, change management, and resolution of product quality issues.
  • Lead and support activities to identify, evaluate, control, communicate, and document product risks throughout development, ensuring risk-management strategies and evidence support product and program decisions.
  • Ensure development strategies and decisions are supported by appropriate technical evidence, Quality rigor, statistical methods, and risk-based rationale; provide independent Quality direction and challenge for complex, ambiguous, or high-risk issues.
  • Build and sustain a high-performing Design Quality team through coaching, performance management, technical development, succession planning, cross-training, and development opportunities; establish clear objectives, expectations, and accountability for results.
  • Align Design Quality resources and individual assignments with business, portfolio, and program priorities while balancing supervisory responsibilities, direct project support, and emerging Quality risks.
  • Partner across Product Development and Quality functions to resolve complex issues, establish clear roles and decision rights, and drive timely, technically sound, compliant, and risk-informed decisions.
  • Ensure significant product, compliance, Quality System, and program risks are visible, appropriately escalated, and driven to resolution; represent Design Quality in cross-functional governance forums and communicate evidence-based recommendations to senior leadership.
  • Ensure appropriate evidence of product and Quality System compliance and readiness, and improve processes, procedures, tools, and methods to strengthen Design Quality performance.

About the Company

Illumina

Develops sequencing platforms and consumables

Illumina develops and sells integrated sequencing systems and the consumables needed to analyze genetic variation and biological function. Its instruments use sequencing-by-synthesis on flow-cell-based platforms, with specialized reagents and library preparation kits that are consumed per run. The company differentiates itself through a broad end-to-end ecosystem, a large installed base that drives repeat purchases, and strategic acquisitions that expand capabilities into multiomics and clinical applications. Its goal is to advance genomic analysis for research and clinical diagnostics to enable personalized medicine and early cancer detection.

Company size
5,001-10,000
Company stage
IPO
Headquarters
San Diego, CA
Founded
1998

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