Director of Quality

Organization
10X Genomics
Job Location
San Francisco Bay Area,
Job Description

By joining 10x Genomics, you can become an integral part of helping enable our customers expand the ways they explore, discover, process and innovate in the field of genomics.

10x Genomics is seeking an accomplished Director of Quality to lead the definition, implementation and management of the company’s Quality Systems. This is a key function required to ensure the success of 10x Genomics through process control and compliance in a rapidly growing company.

The successful candidate with have demonstrated experience building an effective Quality Management System, that spans design controls for new product development as well as manufacturing quality assurance and logistics and customer service. The product development process will follow industry standard guidelines and phase gates from concept to commercialization. Manufacturing quality assurance establishes and manages processes such as discrepancy tracking, CAPA, SPC analysis, LIMS implementation, RMA processing, vendor capability, and other quality metrics. Responsibilities also include driving the preparation, compliance and certification of quality requirements.  This will include ISO, CE, UL.

Qualified candidates require knowledge and experience in life sciences, preferably in Next Generation Sequencing. High level of communication skills are required to ensure seamless communication across the multifunction teams at 10x Genomics. The ideal candidate is self-motivated and driven in implementing and managing world class quality processes.

Key Responsibilities

  • Define and implement 10x Genomics Quality Management System, detailing quality requirements for new product development, manufacturing, logistics, and customer service.
  • Collaborate with development teams and guide them through the appropriate development phases and design reviews, to assure products transition successfully from concept feasibility to manufacturing
  • Develop and manage QA processes required for operations, such as RMA, CAPA, discrepancy reporting
  • Implement the necessary tools to track key quality metrics, establish regulatory requirements and manage the path to compliance as required. ISO, CE, UL
  • Successfully establish a productive working environment with colleagues to create a pull environment of new products from product development into operations
Requirements
  • Bachelor degree or higher in a relevant scientific discipline - Molecular Biology, Analytical Chemistry or Chemical Engineering, with formal training in Quality Assurance management
  • Demonstrated and proven capability in setting up and managing an effective quality system.
  • Minimum of 7 years relevant industrial experience in Life Sciences in a hands on Quality Assurance capacity, demonstrating capability in all aspects of the job requirements
  • Strong teamwork, leadership, organization and communication skills
How to Apply
About Our Organization

10x Genomics meets the critical need for long range, structural and cellular information, with an innovative system that transforms short-read sequencing technologies. Our ChromiumTM System supports comprehensive genomics and high-throughput single cell transcriptomics. It enables researchers to discover previously inaccessible genomic information at unprecedented scale, including phased structural variants, phased single nucleotide variants, and dynamic gene expression of individual cells—while leveraging their existing sequencing systems and workflows.

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