Senior Director, Global Quality

10x Genomics•Pleasanton, CA

1d•Onsite

About The Position

10x Genomics is seeking an accomplished and visionary Senior Director of Global Quality Assurance to lead our global quality strategy. As 10x continues to expand across the Americas, EMEA, and APAC, this leader will be responsible for driving the development, execution, and oversight of our Quality Assurance (QA), Quality Control (QC), and Regulatory/Compliance functions. This individual will partner across Operations, R&D, and Commercial teams to design and implement scalable business processes that align with international quality standards. The role is both strategic and hands-on requiring proven expertise in building and sustaining world-class quality systems that enable innovation while ensuring compliance and operational excellence. The ideal candidate will have a track record of successfully leading organizations through ISO9001 and ISO13485 certifications, building robust Quality Management Systems (QMS), and implementing continuous improvement practices across complex, global operations.

Requirements

Bachelor’s degree or higher in a relevant scientific or engineering discipline (e.g., Molecular Biology, Analytical Chemistry, Chemical Engineering or related engineering discipline). Phd preferred.
15+ years of progressive quality assurance leadership experience in Life Sciences, Diagnostics, or related industries, with proven success in consumables and instrumentation.
Formal training and certification in Quality Assurance management (e.g., Six Sigma, ASQ).
Demonstrated success in establishing and managing effective QMS and Document Control systems in high-growth, complex organizations.
Experience leading organizations through ISO9001 and ISO13485 certification.
Deep understanding of Operations and R&D functions.
Exceptional leadership, organizational development, and communication skills, with a proven ability to influence across all levels of the business.
Ability to manage global quality assurance with consistency, objectivity, and cultural sensitivity.

Responsibilities

Lead and develop the Global Quality Assurance organization, including QA, QC,Quality Systems, Document control and Regulatory/Compliance.
Define and execute the global quality vision, strategy, and metrics to support company growth and regulatory compliance.
Serve as the executive sponsor for global quality initiatives, including ISO13485 certification.
Oversee the continued development and governance of the company’s Quality Management Systems (QMS, LIMS, GLP and Training).
Ensure effective CAPA, NCR, RMA, and discrepancy reporting processes are in place and continuously improved.
Establish and manage supplier quality, design quality, and process quality systems.
Drive compliance with global standards (ISO, FDA, CE, UL, TUV and country-specific Safety Data Sheets) and lead product certification processes (e.g., 510(k)).
Partner with R&D, Program Management, and Operations to embed quality throughout the product development lifecycle.
Lead Quarterly Quality Reviews, report on global quality metrics, and ensure timely execution of corrective actions.
Act as a trusted advisor to senior leadership on quality-related risk management and compliance strategies
Act as the company interface with customers for quality or regulatory issues
Champion Lean Six Sigma and Statistical Process Control (SPC) initiatives to reduce defects and field failures.
Implement scalable systems and workflow automation to improve efficiency and compliance.
Drive a culture of accountability, transparency, and continuous improvement across the organization.