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Quality Manager, Scientific Operations-Temp
Natera
CAN
Manager · 5+ years experience
Discovered 1 weeks ago
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NateraTM is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health.
Our mission is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that help lead to longer, healthier lives.
Natera’s tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy.
As Quality Manager, Scientific Operations, you will own quality management across the team, spanning the Sample Management and Sample Operations functions.
Working in close partnership with the Natera QA team, you will be responsible for following, maintaining, and improving existing quality frameworks, compliance structures, and QA/QC systems within Scientific Operations.
You will manage day-to-day quality assurance operations including audits, SOP governance, and document control, and will proactively identify and drive improvements where processes need strengthening.
This role reports to the Director of Scientific Operations.
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QUALIFICATIONS
- B.S. or M.S. in Life Sciences, or a related field.
- 5+ years of experience in Quality Assurance or Quality Management within a biotech, clinical lab, or diagnostics setting.
- Hands-on CAP compliance experience; familiarity with CAP inspection processes and checklist requirements.
- Familiarity with biobank regulations and certification standards (e.g., ISBER, BBMRI, or equivalent).
- Deep understanding of GLP, GxP, ISO 9001/17025 quality frameworks and their practical application in lab settings.
- Experience leading or supporting internal and external quality audits, with demonstrated ability to drive corrective and preventive actions.
- Experience at an early-stage or startup company with direct responsibility for building or significantly maturing QA/QC systems is a plus.
- KNOWLEDGE, SKILLS & ABILITIES
- Fluent in QA language and terminology; able to communicate compliance requirements clearly to both scientific and operational audiences.
- Strong technical writing skills with demonstrated ability to independently draft, revise, and finalize SOPs, work instructions, and quality documents to regulatory standards.
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