Manager, Quality Assurance, Scientific Operations

Natera•San Carlos, CA

3d•Hybrid

About The Position

Natera™ 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 QA 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.

Requirements

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.

Nice To Haves

Experience at an early-stage or startup company with direct responsibility for building or significantly maturing QA/QC systems is a plus.
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.
Entrepreneurial mindset — comfortable building structure in ambiguous environments and proposing pragmatic solutions.
Strong attention to detail with a rigorous, systematic approach to auditing and documentation review.
Diplomatic and objective communication style — able to enforce compliance without stifling scientific agility.
Able to manage competing priorities across multiple teams and stakeholders simultaneously.
Strong written communication skills for audit findings, CAPA documentation, and regulatory submissions.

Responsibilities

Collaborate closely with the Natera QA team to maintain and follow the Quality Management System (QMS), ensuring Scientific Operations operates in full alignment with company-wide quality standards.
Lead the design and improvement of QA/QC processes across Scientific Operations; identify gaps in existing systems and implement practical, scalable solutions.
Propose and drive continuous improvements to existing quality workflows, recommending changes that strengthen compliance without disrupting scientific operations.
Serve as the primary QA contact within Scientific Operations, connecting closely with the Natera QA team and providing guidance on quality language, standards, and interpretation.
Lead Root Cause Analysis (RCA) and CAPA processes for quality deviations, non-conformances, or audit findings.
Train Scientific Operations staff on QA/QC expectations, documentation standards, and regulatory requirements.
Conduct systematic spot-checks and routine audits of lab run packages, sample logs, and experimental records across Scientific Operations, including both Sample Management and Sample Operations.
Manage the full lifecycle of SOPs, technical protocols, equipment calibration logs, and safety documents, including version control and periodic review cycles.
Support internal and external audit readiness by maintaining organized, traceable, and audit-ready documentation systems.
Flag non-compliant or incomplete documentation; work directly with lab staff and management to resolve gaps and implement corrective actions.
Partner with scientific staff to enforce data-logging standards within LIMS, ensuring raw data, metadata, and reports meet quality requirements.