Vice President, Laboratory Operations

Responsibilities

• Develop and execute strategic initiatives to optimize laboratory operations, focusing on quality, capacity, TAT, and COGS
• Lead and manage high-performing teams, ensuring accountability for customer satisfaction and departmental KPIs
• Contribute to budget preparation and monitor revenue, expenses, test volume, and FTE utilization
• Serve as the primary contact for delegated products, providing updates to executive leadership
• Ensure adherence to quality programs, ISO 13485 standards, FDA requirements (CLIA and QSR), GDP, and GCP/cGMP
• Drive continuous improvement initiatives using Lean Six Sigma principles
• Lead, coach, mentor, and develop team members
• Represent the company during audits, client visits, and technical calls

Requirements

• BS/BA degree in a STEM-related field (Biological Sciences preferred)
• 12+ years of relevant experience with a BS, 10+ years with an MS, or 7+ years with a PhD
• 5+ years of experience overseeing manufacturing at a Director or Senior Manager level
• Ability to travel up to 25%
• Proficiency in Microsoft Office Suite, particularly Excel
• Knowledge of ISO 13485, FDA requirements (42 CFR 493 and 21 CFR 820), GDP, and GCP/cGMP
• Experience with Lean Six Sigma and LDT laboratory operations

Preferred Qualifications

• Current California CLS or CGMBS license

About the Company

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health, aiming to make personalized genetic testing and diagnostics part of the standard of care.