Manager, Quality Assurance, Scientific Operations

📋 Description

• Own quality management across Sample Management and Sample Operations.
• Maintain and improve QA/QC systems, audits, SOP governance, and document control.
• Lead QA/QC process design, identify gaps, and implement practical solutions.
• Drive continuous improvements to quality workflows with regulatory alignment.
• Serve as primary QA contact within Scientific Operations; align with Natera QA standards.
• Lead RCA and CAPA for deviations, non-conformances, or audit findings.

🎯 Requirements

• B.S. or M.S. in Life Sciences or related field.
• 5+ years in Quality Assurance/Quality Management in biotech, clinical lab, or diagnostics.
• Hands-on CAP compliance experience; CAP inspection familiarity.
• Familiarity with biobank regs (ISBER, BBMRI, etc.).
• Deep understanding of GLP, GxP, ISO 9001/17025 and practical lab application.
• Experience leading or supporting internal/external quality audits with CAPA.

🎁 Benefits

• Health benefits (medical, dental, vision), life and disability coverage.
• 401(k) with company match; generous PTO and holidays.
• Wellness and work-life benefits; Total Rewards program.