Contract
Quality Manager
Scientific Operations
Natera
5,001-10,000 employees
Genetic testing for cancer, transplant, pregnancy
Compensation Overview
$55/hr
Company Historically Provides H1B Sponsorship
San Carlos, CA, USA
Hybrid
The role is described as office or hybrid; occasional work outside normal business hours may be required.
Bachelor's, Master's
 Biology & Biotech (1) |
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- A B.S. or M.S. in Life Sciences or a related field is required.
- At least 5 years of experience in Quality Assurance or Quality Management within a biotech, clinical laboratory, or diagnostics setting is required.
- Hands-on College of American Pathologists compliance experience is required, including familiarity with College of American Pathologists inspection processes and checklist requirements.
- Familiarity with biobank regulations and certification standards, such as ISBER and BBMRI, is required.
- A deep understanding of Good Laboratory Practice, GxP, ISO 9001, and ISO 17025 quality frameworks and their practical application in laboratory settings is required.
- Experience leading or supporting internal and external quality audits, with the ability to drive corrective and preventive actions, is required.
- Fluency in quality assurance language and terminology is required.
- Strong technical writing skills are required, including the ability to independently draft, revise, and finalize standard operating procedures, work instructions, and quality documents to regulatory standards.
- A rigorous and systematic approach to auditing and documentation review is required.
- The ability to manage competing priorities across multiple teams and stakeholders simultaneously is required.
- Strong written communication skills are required for audit findings, corrective and preventive action documentation, and regulatory submissions.
- The role requires computer keyboard use, video conferencing and telephone communication, and the ability to read printed material.
- Own quality management across the Sample Management and Sample Operations functions within Scientific Operations.
- Partner with the Natera Quality Assurance team to follow, maintain, and improve quality frameworks, compliance structures, and quality assurance/quality control systems.
- Lead the design and improvement of quality assurance and quality control processes across Scientific Operations.
- Identify gaps in existing quality systems and implement practical, scalable solutions.
- Drive continuous improvements to quality workflows and recommend changes that strengthen compliance without disrupting scientific operations.
- Serve as the primary quality assurance contact within Scientific Operations and provide guidance on quality language, standards, and interpretation.
- Lead Root Cause Analysis and corrective and preventive action processes for quality deviations, non-conformances, and audit findings.
- Train Scientific Operations staff on quality assurance and quality control expectations, documentation standards, and regulatory requirements.
- Conduct systematic spot-checks and routine audits of laboratory run packages, sample logs, and experimental records across Sample Management and Sample Operations.
- Manage the full lifecycle of standard operating procedures, technical protocols, equipment calibration logs, and safety documents, including version control and periodic review cycles.
- Maintain organized, traceable, and audit-ready documentation systems to support internal and external audit readiness.
- Identify non-compliant or incomplete documentation, work with laboratory staff and management to resolve gaps, and implement corrective actions.
- Partner with scientific staff to enforce data-logging standards within the laboratory information management system, ensuring raw data, metadata, and reports meet quality requirements.
- Work in an office or hybrid office environment and occasionally work outside normal business hours to support project timelines and cross-functional coordination.
- Experience at an early-stage or startup company with direct responsibility for building or significantly maturing quality assurance and quality control systems is preferred.
Natera provides genetic testing and diagnostics using cell-free DNA (cfDNA) from a patient’s blood to guide medical decisions. Its tests include MRD and ctDNA profiling for cancer, the personalized Signatera test, organ transplant health assessment, and Panorama NIPT for prenatal screening. The company combines cfDNA-based results with remote access and genetic counseling to support clinicians and patients. Its goal is to deliver accurate, noninvasive tests that improve treatment decisions and patient outcomes at scale.
Company Size
5,001-10,000
Company Stage
IPO
Headquarters
Austin, Texas
Founded
2004
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Simplify's Take
What believers are saying
- Q2 2026 revenue hit $752.8 million, up 37.7%, and guidance rose.
- Signatera volumes exceeded 280,000 in Q2 2026, driven by bladder and colorectal adoption.
- Europe and Japan open new reimbursement pathways beginning late 2026 and early 2027.
What critics are saying
- CareDx's June 2026 Supreme Court loss leaves Prospera liability unresolved.
- Guardant litigation in 2026 threatens Natera's MRD branding, remedies, and distraction.
- FIND-CRC needs roughly $500 million before launch; reimbursement failure cripples 2027 growth.
What makes Natera unique
- Signatera became the first FDA-approved personalized MRD test in 2026.
- Natera won Japan PMDA approval and EU IVDR certification for Signatera.
- Austin lab scale and proprietary bioinformatics deepen its cfDNA testing moat.
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Benefits
Flexible medical plans
Investment options
Time off
Workplace perks
Growth & Insights and Company News
6 month growth
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↑ 0%Natera teams with Angiex on cancer drug trial monitoring. * August 31, 2026 Natera inked a collaboration deal with biotech Angiex to assess the use of its Signatera blood test, which looks for small traces of cancer DNA in patients who have been diagnosed and treated for the disease.
Natera has partnered with Kupando Therapeutics to supply its Latitude tissue-free minimal residual disease (MRD) assay for a Phase 1 immunotherapy trial in multiple skin cancers. The assay will monitor disease and treatment response in patients receiving Kupando's investigational therapy. The collaboration extends Natera's MRD technology into early-stage drug development settings. Natera is a US-based molecular diagnostics company that develops and commercialises testing services. The partnership expands Natera's presence in oncology clinical trials and supports use of its MRD technology across different tumour types. However, the revenue impact from these early-stage trial deployments is likely modest at this stage. Investors will watch whether additional oncology trials adopt Natera's platforms and if the company begins disclosing trial counts or patient volumes linked to MRD collaborations.
Natera reported second-quarter results that beat analyst expectations, driven by strong test volume growth and momentum across its product portfolio. Revenue reached $752.8 million, exceeding estimates by 13.6%, whilst adjusted EPS of -$0.47 beat forecasts. CEO Steven Chapman attributed the performance to record test volumes, particularly for Signatera in oncology, and the launch of an enhanced Panorama prenatal test. The company secured FDA and Japanese regulatory approvals for Signatera during the quarter. Operating margin improved to -10.1% from -20.2% year on year. Sales volumes rose 22.4% compared to the prior year. During the earnings call, analysts questioned the sustainability of Signatera's growth trajectory and future pricing potential. Chapman acknowledged emerging competition in MRD testing but noted that low market penetration leaves substantial room for expansion.
Natera spotlights record Signatera volumes, raises outlook at Canaccord Conference. August 15, 2026 Key points. * Natera raised its outlook after broad-based second-quarter momentum, including record Signatera volumes, strong revenue and pricing, improved gross margins, and narrowing losses despite continued investment. * Signatera volumes exceeded 280,000 units, rising about 34,000 sequentially, supported by clinical data, regulatory and guideline milestones in bladder cancer, and recent commercial expansion. * Natera is expanding laboratory capacity and international coverage while investing heavily in early cancer detection; its FIND-CRC study is nearing enrollment completion, though the program currently weighs on profitability. * MarketBeat previews top five stocks to own in September. Natera NASDAQ: NTRA Chief Financial Officer Mike Brophy said the company delivered strong second-quarter momentum across its women's health, oncology and organ health businesses, citing record Signatera volumes, continued revenue and average selling price strength, improved gross margins and narrowing losses while maintaining elevated investment levels. Speaking at the Canaccord Genuity Growth Conference, Brophy said Natera raised its outlook following a quarter in which volume performance was broad-based. He described organ health momentum as "very strong" and said women's health posted high-single-digit year-over-year growth despite typically experiencing seasonal sequential declines. Women's health momentum and product updates. Brophy attributed part of the women's health performance to uptake of Natera's Fetal Focus offering, which launched several quarters ago and continued to gain traction through the second quarter. He also highlighted the June launch of a new version of the Panorama non-invasive prenatal testing assay. The updated Panorama test is designed to offer greater sensitivity, particularly in cases with low fetal fraction, an area that Brophy said has historically been challenging for non-invasive prenatal testing. Because the launch occurred in early June, he said it was not a significant driver of second-quarter results but could support women's health performance during the remainder of the year. While Brophy characterized the quarter as exceptional, he said his typical framework for women's health is mid-single-digit volume growth, with the opportunity for faster revenue growth if Natera can increase reimbursement realization for covered services. Record Signatera volumes. The company's oncology business, led by its Signatera molecular residual disease and recurrence-monitoring test, reached more than 280,000 units during the quarter. Brophy said the company added approximately 34,000 units sequentially, compared with a prior quarterly record increase of about 25,000 units. He noted that first-quarter Signatera volumes were somewhat affected by weather-related disruptions. Natera estimates that roughly 2,000 to 4,000 units that otherwise may have been received in the first quarter arrived later, contributing to the magnitude of the second-quarter sequential increase. Even excluding that effect, Brophy called the quarter an "absolute blowout." He cited several drivers of Signatera's growth: * Continued generation of clinical outcomes data for Signatera and molecular residual disease testing. * FDA approval related to Signatera's use in muscle-invasive bladder cancer. * Inclusion in National Comprehensive Cancer Network guidelines for muscle-invasive bladder cancer in June. * The full operational impact of a commercial expansion completed around April. Brophy said newer offerings, including Genome and Latitude, accounted for only a small portion of total Signatera volume. However, he said their availability broadens the company's product menu and may enhance Signatera's positioning with physicians. Coverage, international expansion and laboratory investment. Natera expects to continue pursuing reimbursement coverage on a tumor-type-by-tumor-type basis, Brophy said. He described the company's interactions with MolDX, Medicare's molecular diagnostic services program, as positive and said Natera has now achieved coverage across much of the critical mass of common tumor types. The company is now working on additional, less common cancers, he said. In Japan, Natera has received PMDA approval for Signatera and has submitted for bladder cancer coverage following its approval in colorectal cancer. Brophy said the company remains on track for an early 2027 Japanese launch. The next steps include discussions with Japanese agencies regarding the number of reimbursed testing time points and pricing, which he expects to be addressed in the second half. The company is also expanding laboratory capacity. Brophy said Natera's Austin, Texas, laboratory is expected to become the world's largest genomics laboratory once its current expansion is completed. First-half capital expenditures increased to approximately $85 million from about $45 million in the prior-year period. He said the elevated spending level is not expected to represent ongoing maintenance capital expenditures, which he estimated at closer to $60 million annually. Early cancer detection investment. Brophy said Natera remains ambitious in early cancer detection, where its FIND-CRC study is approaching enrollment completion at up to 40,000 patients. He emphasized the expense and complexity of bringing a blood-based early cancer detection assay to market, estimating that a company may need to spend roughly $500 million before selling its first test when clinical development and regulatory work are included. Rather than immediately building a large commercial team, Brophy said Natera expects to use a phased approach, deploying an initial group of sales representatives in selected geographies and expanding based on early results and returns on invested capital. He acknowledged that early cancer detection spending is currently weighing on the company's overall profit profile because the program is generating operating expenses without revenue or gross profit. Still, he said Natera is seeing losses narrow while continuing to invest in research and development, Signatera clinical studies and commercial growth initiatives. Looking internationally, Brophy said Natera sees significant demand for Signatera in Europe following IVDR approval. He said reimbursement opportunities will need to be evaluated country by country and use case by use case, while noting that the company is conducting clinical studies in Europe, including CIRCULATE-France. About Natera (NASDAQ:NTRA). Natera is a global diagnostics company that develops and commercializes cell-free DNA and other genetic testing technologies for clinical applications. The company focuses on three principal areas: reproductive health (including non-invasive prenatal testing and carrier screening), oncology (tumor-informed assays for minimal residual disease and recurrence monitoring), and organ transplantation (cell-free DNA tests to detect allograft injury). Natera combines laboratory testing, proprietary bioinformatics, and clinical reporting to deliver personalized genetic information to clinicians and patients. Key product offerings include Panorama, a non-invasive prenatal test that screens for fetal chromosomal abnormalities and select single-gene conditions; Horizon carrier screening for inherited conditions; Signatera, a personalized, tumor-informed assay used for detecting minimal residual disease and monitoring treatment response in cancer patients; and Prospera, a donor-derived cell-free DNA test used to assess the risk of organ rejection. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. Continue following MarketBeat Before you consider Natera, you'll want to hear this. MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Natera wasn't on the list. While Natera currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. The AI wave will soon hit public markets with Anthropic and OpenAI set to go public later this year. However, you don't have to wait to invest. This report shows seven AI stocks that you can buy today while the big model providers get ready to go public.
Genetic testing company Natera reported second-quarter revenues of $752.8 million, up 37.7% year on year and beating analyst estimates by 13.6%. The company raised its full-year revenue guidance to $2.88 billion, 3% above consensus. Sales volumes rose 22.4% year on year. CEO Steven Chapman attributed the results to record test volumes, particularly for Signatera in oncology, and the launch of an enhanced Panorama prenatal test. The quarter also saw FDA and Japanese regulatory approvals for Signatera. Operating margin improved to -10.1%, up from -20.2% in the same quarter last year. Management linked this to higher average selling prices and scaling of recently launched products. The company expects continued volume growth across its testing franchises, with investments in clinical trials and early cancer detection driving future expansion.