10x Genomics · 2 hours ago
Senior Director, Global Quality
Pleasanton, CA
Full-time
Onsite
Director/Executive
$230K/yr - $311K/yr
15+ years exp10x Genomics is seeking an accomplished and visionary Senior Director of Global Quality Assurance to lead their global quality strategy. The role involves driving the development, execution, and oversight of Quality Assurance, Quality Control, and Regulatory/Compliance functions while partnering with various teams to ensure compliance with international quality standards.
Biotechnology
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
Qualification
Required
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
Benefits
Equity grants
Comprehensive health and retirement benefit programs
Annual bonus program or sales incentive program
Company
10x Genomics
Cells are the basic unit of life.
1001-5000 employees
H1B Sponsorship
10x Genomics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (41)
2024 (40)
2023 (35)
2022 (52)
2021 (34)
2020 (16)
Funding
Current Stage
Late StageLeadership Team
Serge Saxonov
Co-founder and CEO
Eric Whitaker
Executive Vice President and Chief Legal Officer
Recent News
2024-05-07
2024-04-30
2024-04-08
Company data provided by crunchbase