Quality Manager

Manager, Quality Assurance, Scientific OperationsSan Carlos, CAPOSITION SUMMARYNatera™ 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.PRIMARY RESPONSIBILITIESQA/QC System Maintenance & ImprovementCollaborate 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.Audit, Documentation & SOP ManagementConduct 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.QUALIFICATIONSB.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 & ABILITIESFluent 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.PHYSICAL DEMANDS & WORK ENVIRONMENTDuties are typically performed in an office or hybrid office environment.This position requires the ability to use a computer keyboard, communicate over video conferencing platforms and telephone, and read printed material.Duties may require working outside normal business hours at times to support project timelines and cross-functional coordination.The role may involve extended periods of sitting and computer-based work.Travel required for this position: No or Yes ___ : If yes, state anticipated percent for travel: Up to 10%Compensation & Total Rewards This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and skills considerations. This position is also eligible for additional compensation and benefits through Natera's robust Total Rewards program, including: Comprehensive health benefits (medical, dental, vision) 401(k) with company match Generous paid time off and company holidays Additional wellness and work-life benefitsCompensation Range$55 - $55 USDOUR OPPORTUNITYNatera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim 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 lead to longer, healthier lives.The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.WHAT WE OFFERCompetitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.If you are based in California, we encourage you to read this important information for California residents.For more information: - BBB announcement on job scams - FBI Cyber Crime resource page