Vice President of Global Quality

San Diego, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Genomic TechnologyIndustries

Requirements

Candidates must possess a Bachelor's degree in Engineering, Life Sciences, or a related technical field, with a Master's degree being preferred. A minimum of 20 years of progressive quality leadership experience in the medical device, pharmaceutical, or combination product industries is required, along with extensive knowledge of global regulatory standards such as FDA, ISO 13485, ISO 14971, EU MDR, MDSAP, and applicable IEC standards. A proven track record in leading FDA and international regulatory inspections and implementing corrective actions is also necessary.

Responsibilities

The Vice President of Global Quality will develop and execute the company's quality vision and strategy, leading global teams across Quality Assurance, Quality Systems, Supplier Quality, Design Quality, Software Quality, Quality Compliance, and Risk Management. Responsibilities include ensuring compliance with global regulatory standards, overseeing the Quality Management System, leading supplier quality programs, providing quality oversight for labs and external partners, and driving digital transformation initiatives within quality processes. The role also involves developing quality metrics, cultivating a proactive quality culture, managing departmental budgets, and serving as a key liaison with customers and regulatory bodies.

Skills

Quality Assurance

Quality Systems

Supplier Quality

Design Quality

Software Quality

Quality Compliance

Risk Management

FDA

ISO 13485

EU MDR

ISO 14971

MDSAP

Change Management

Regulatory Standards

Global Quality

Illumina

Supports genomics startups through funding and resources

About Illumina

Illumina focuses on fostering innovation in the genomics industry by supporting startups through its Illumina Accelerator program. This program helps entrepreneurs create, launch, and grow genomics-focused companies by providing funding and resources. The accelerator operates in two main locations: the San Francisco Bay Area and Cambridge, UK. Illumina Accelerator has successfully invested in 68 genomics startups, which have collectively raised over $1 billion in venture capital. What sets Illumina apart from its competitors is its strong partnership with leading venture capital investors and its dedicated focus on the genomics sector. The goal of Illumina is to build a thriving ecosystem for genomics innovation, enabling new companies to emerge and advance the field.

San Diego, CaliforniaHeadquarters

1998Year Founded

$27.2MTotal Funding

IPOCompany Stage

Venture Capital, BiotechnologyIndustries

5,001-10,000Employees

Risks

Over-reliance on NVIDIA's AI technology may limit flexibility in AI solution adoption.

Standardizing proteomics data across platforms could challenge Illumina's data reliability.

Single-flow-cell NovaSeq X System might cannibalize sales of higher-end models.

Differentiation

Illumina leads in genomic sequencing with advanced AI integration and multiomic data analysis.

The company offers innovative array-based solutions for DNA, RNA, and protein analysis.

Illumina's global expansion includes a new Global Capability Center in Bengaluru.

Upsides

Collaboration with NVIDIA enhances drug discovery and clinical development through AI integration.

Pilot proteomics program with UK Biobank aims to generate crucial reference datasets.

Single-cell sequencing kits make high-throughput sequencing accessible to smaller labs.

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