Full-Time
Sr. Quality Specialist
Supplier QA
Posted on 10/31/2025
Veracyte
501-1,000 employees
Genomic cancer diagnostics and non-invasive tests
Compensation Overview
$117k - $130k/yr
San Bruno, CA, USA
Hybrid
Hybrid role; requires at least 3 days on-site per week.
 QA & Testing (3) |
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- Bachelor’s degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field
- 5+ years hands‑on quality assurance experience in the medical device or in‑vitro diagnostic (IVD) industry
- In‑depth knowledge of in‑vitro diagnostic device quality requirements, including ISO 13485:2016, IVDR (EU 2017/746) and, ISO 14971:2019 risk management
- Strong background in supplier quality management and oversight of CMOs
- Proven experience conducting supplier audits and managing supplier corrective actions
- Willingness to travel (up to ~30%) to supplier and CMO sites
- Strong written and verbal communication skills; demonstrated ability to author clear SOPs, technical documents, and audit responses
- Strong organization skills to manage multiple simultaneous projects in a fast-paced environment
- Attention to detail in understanding and documenting complex quality issues
- Highly organized, self-motivated, and comfortable working in a fast-paced IVD environment
- ISO 13485 Lead Auditor or equivalent lead auditor certificate is preferred
- Partner closely with internal stakeholders and external manufacturing partners to ensure products are manufactured in compliance with applicable regulations (e.g., FDA, ISO 13485, EU IVDR, etc.) and Veracyte’s quality standards
- Collaborate with internal stakeholders such as R&D and Supply Chain to define supplier selection criteria and ensure new suppliers are qualified according to established procedures
- Conduct suppliers and CMOs quality audits and ensure timely closure of audit findings
- Develop, implement, and maintain supplier quality metrics and monitoring programs
- Lead or support investigations of supplier and CMO related quality incidents, perform root cause analysis, assess impact on product or regulatory compliance
- Develop and maintain Approved Supplier Lists (ASL) and associated documentation
- Lead suppliers and CMOs qualification activities, including risk assessments, audits, and quality agreements
- Issue, track, and close Supplier Corrective Action Requests (SCARs) related to supplier non-conformances
- Review and approve supplier change notifications and deviations to assess the impact on IVD product quality and regulatory compliance.
- Ensure appropriate validation and verification activities are performed for supplier-initiated changes
- Collaborate with R&D during product design and development to ensure supplier capabilities meet design requirements and specifications for new IVD products
- Collaborate cross-functionally to manage technical transfers, validations, and new product introductions at CMOs
- Support internal and external audits (e.g., FDA, Notified Body) related to supplier quality and provide necessary documentation and evidence
- Drive continuous improvement of supplier management processes and standards
- ISO 13485 Lead Auditor or equivalent lead auditor certificate is preferred
Veracyte develops and sells genomic tests used to detect and diagnose cancer. Its tests are non-invasive when possible, using samples such as nasal swabs or tissue biopsies to analyze genetic information and help determine cancer risk or prognosis. One of its notable offerings is the Decipher Prostate genomic classifier, which estimates prostate cancer prognosis, alongside other tests for early lung cancer risk assessment. The company works with hospitals, clinics, and individual practitioners to provide tools that improve diagnostic accuracy and guide treatment decisions. Veracyte differentiates itself by focusing on clinically validated, non-invasive genomic assays that support early detection and personalized care, and by expanding its test portfolio through ongoing research and clinical studies. Its goal is to help healthcare providers achieve earlier, more accurate cancer diagnoses, improve patient outcomes, and use medical resources more efficiently.
Company Size
501-1,000
Company Stage
IPO
Headquarters
San Francisco, California
Founded
2008
Simplify's Take
What believers are saying
- Decipher Prostate already has Medicare coverage, supporting reimbursement and adoption.
- Prosigna launched in the U.S. on June 8, 2026, expanding breast oncology.
- TrueMRD received Medicare coverage and begins commercial launch on June 1, 2026.
What critics are saying
- Quest Diagnostics can pressure Veracyte's thyroid business through distribution scale.
- Prosigna faces entrenched chemotherapy habits and slow physician switching after launch.
- TrueMRD depends on payer utilization; weak adoption would quickly impair economics.
What makes Veracyte unique
- Veracyte combines whole-genome and transcriptome analytics into a single diagnostics platform.
- Its three U.S. labs support national testing and faster turnaround times.
- The portfolio spans thyroid, prostate, breast, bladder, and lung cancer tests.
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Growth & Insights and Company News
6 month growth
↓ -2%1 year growth
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↓ -1%Veracyte launches test identifying breast cancer patients who don't need chemo. June 3, 2026 Buoyed by the remarkable results of the OPTIMA trial presented at the ASCO Annual Meeting, Veracyte this week announced the U.S. launch of the Prosigna Breast Risk of Recurrence (ROR) test, a genomic test for patients diagnosed with early-stage hormone-receptor positive (HR+) breast cancer. "Prosigna is the only test proven to be predictive for chemotherapy benefit in a Phase III prospective trial for patients with up to nine positive lymph nodes, including premenopausal women, all of whom were recommended to receive ovarian suppression," Phillip G. Febbo, MD, chief scientific and medical officer at Veracyte, told Inside Precision Medicine. The Prosigna test determines a patient's ROR score and estimates the 10-year probability of distant recurrence. It thus help guide treatment decisions, including predicting whether high risk patients are likely to benefit from chemotherapy or may safely achieve optimal outcomes with endocrine therapy alone, helping clinicians to make personalized care plans for their patients. Prosigna will be available to order starting June 8, 2026. "Every patient diagnosed with breast cancer deserves answers they can trust about what their cancer means and what comes next," said John Leite, PhD, chief commercial officer, Veracyte. "Prosigna gives patients and their oncologists a deeper understanding of their individual risk of recurrence, and, for many, whether chemotherapy will truly benefit them or whether they can safely avoid it. That kind of personalized insight can bring greater confidence and reassurance as patients navigate decisions that will shape their care and future health." In the U.S., more than 225,000 new HR+/HER2- breast cancer cases are diagnosed each year. When breast cancer is diagnosed early and treated appropriately, five-year survival rates reach 92%. "For decades, clinical staging just comprised tumor size and nodal status together with pathology. This was the standard approach to determining whether patients with HR+/HER2- breast cancer need chemotherapy. Many node-positive patients routinely receive chemotherapy as standard of care," Febbo said. He added, "And yet, chemotherapy is likely to only benefit a relatively small fraction of these patients." The OPTIMA trial uses the Prosigna test to guide therapy and testing. Those patients with a low Prosigna ROR (<60) can safely avoid chemotherapy. OPTIMA shows that tumor biology, as evaluated by the Prosigna test, provides information beyond traditional clinical factors. Prosigna is based on the PAM50 genomic classifier, which classifies tumors into four intrinsic subtypes. Prosigna, the company said in a press release, "uniquely combines intrinsic subtypes and proliferation score with clinical pathological factors into a single comprehensive analysis to calculate a patient's Risk of Recurrence (ROR) score and predict 10-year probability of distant recurrence." Veracyte's portfolio includes multiple cancer types, including tests for prostate cancer (Decipher Prostate), bladder cancer (Decipher Bladder and TrueMRD for muscle invasive bladder cancer monitoring), and others. The company said, "Prosigna's intrinsic subtyping data positions us well for future expansion. While ROR scoring is specific to HR+/HER2- disease, the underlying intrinsic subtyping information spans all breast cancer types." More than 225,000 new HR+/HER2- breast cancer cases are diagnosed annually, with approximately 75,000 patients having node-positive disease annually. The OPTIMA trial demonstrated that more than two-thirds of clinically high-risk patients (68%) can safely avoid chemotherapy - a significant population previously assumed to require treatment based solely on nodal status.
Veracyte, a molecular diagnostic company based in South San Francisco, reported fourth-quarter net income of $41.1 million, or 53 cents per share on an adjusted basis, beating Wall Street expectations of 41 cents per share. Revenue reached $140.6 million in the quarter. For the full year, the company posted profit of $66.4 million, or 82 cents per share, on revenue of $517.1 million. Veracyte expects full-year revenue between $570 million and $582 million, indicating continued growth in its diagnostics business.
Veracyte advances urologic cancer care with robust data at 2026 ASCO GU Symposium. Veracyte showcases over 15 abstracts highlighting Decipher and TrueMRD genomic tests. What if genomic tests could revolutionize the way The Pharma Data treat urologic cancers? Veracyte, Inc. a leading cancer diagnostics company, is making significant strides in this direction. The company will present more than 15 abstracts at the 2026 ASCO Genitourinary Cancers Symposium (ASCO GU), which takes place from February 26-28 in San Francisco. These studies span prostate and bladder cancers, featuring real-world data for Decipher Prostate and new insights from phase II clinical trials, including one utilizing the company's upcoming TrueMRD(TM) Muscle-Invasive Bladder Cancer (MIBC) test. The breadth of data at ASCO GU shows how its Veracyte Diagnostics Platform is driving meaningful insight across multiple urologic cancers," said Elai Davicioni, Ph.D., Veracyte's medical director, Urology. "In bladder cancer, Decipher is increasingly being integrated into studies that aim to help guide treatment decisions. With TrueMRD, its whole-genome sequencing minimal residual disease platform, The Pharma Data is extending the understanding of tumor evolution and treatment resistance, while also providing critical information to ensure the earlier detection of recurrent disease when a cure may still be achievable. Key insights at a glance. * Decipher Prostate: A 22-gene test that helps inform treatment decisions for patients with prostate cancer. * Decipher Bladder: A 219-gene test that classifies bladder tumors into five molecular subtypes. * TrueMRD: A whole-genome sequencing minimal residual disease platform for tracking cancer recurrence and evolution. * ASCO GU Symposium: Features over 15 abstracts highlighting Veracyte's urology portfolio. The challenge of precision in urologic cancer care. Just as a navigator uses a detailed map to chart a course, Veracyte is using genomic data to guide clinicians in making more precise treatment decisions for urologic cancers. The company's Decipher and TrueMRD tests are designed to provide critical insights into tumor biology and patient outcomes, addressing the significant challenge of tailoring treatments to individual patient needs. This precision is crucial in an era where one-size-fits-all approaches are increasingly recognized as inadequate. The stakes are high, as more accurate and personalized treatments can lead to better patient outcomes and potentially save lives. Why the window for action is closing fast. Like a race against time, the rapid evolution of cancer biology demands immediate and informed action. Veracyte's robust data from the 2026 ASCO GU Symposium underscores the urgency of integrating genomic tests into clinical practice. The SURE-02 phase II trial, for example, highlights the importance of molecular subtyping in muscle-invasive bladder cancer, suggesting a biologically informed strategy for the use of anti-TROP2 ADCs. This approach not only enhances the effectiveness of current treatments but also paves the way for the development of new, more targeted therapies. The conference will provide a platform for clinicians and researchers to share these findings and accelerate the adoption of precision-based care. Veracyte mobilizes genomic insights for clinical decision-making. Veracyte is at the forefront of advancing urologic cancer care through its comprehensive genomic testing platform. The company's Decipher Prostate and Decipher Bladder tests are already making a significant impact, with the Decipher Prostate test achieving "Level 1B" evidence status and inclusion in the most recent NCCN(R) Guidelines for prostate cancer. The upcoming TrueMRD MIBC test, set to be available in the first half of 2026, will further enhance the ability to monitor and manage cancer recurrence. Veracyte continues to strengthen the connection between real-world data and clinical outcomes, ensuring that its tests provide actionable insights for clinicians and patients alike. Future outlook. Veracyte's genomic tests are like a lighthouse guiding ships through treacherous waters, providing clear and reliable information to navigate the complexities of urologic cancer care. The company's commitment to innovation and collaboration is evident in the breadth and depth of the data being presented at the 2026 ASCO GU Symposium. With the upcoming TrueMRD MIBC test and ongoing research, Veracyte is poised to continue driving meaningful advancements in the field. Conclusion. The 2026 ASCO GU Symposium marks a significant milestone for Veracyte and the broader urologic cancer community. By leveraging genomic insights, the company is empowering clinicians to make more informed and precise treatment decisions, ultimately improving patient outcomes. Join the conversation in the comments below. About Decipher Prostate The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients with prostate cancer. The test is performed on biopsy or surgically resected samples and provides an accurate risk of developing metastasis with standard treatment. Armed with this information, physicians can better personalize their patients' care and may recommend less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test has been validated in many dozens of published studies involving more than 100,000 patients. It is the only gene expression test to achieve "Level 1B" evidence status and inclusion in the risk-stratification table in the most recent NCCN(R) Guidelines* for prostate cancer. About Decipher Bladder The Decipher Bladder Genomic Classifier is a 219-gene test, developed using RNA whole-transcriptome analysis and machine learning, that is designed for use in patients following bladder cancer diagnosis who face questions regarding treatment intensity. The test classifies bladder tumors into five molecular subtypes, each having distinct tumor biology and potential clinical implications. This information can help physicians and their patients better understand the degree of benefit that would likely be gained from neoadjuvant chemotherapy and/or the likelihood of harboring non-organ-confined disease at time of surgery, respectively.
UBS has reaffirmed its Buy rating on Veracyte with a $48 price target following strong fourth-quarter performance. The genomic diagnostics company reported preliminary Q4 2025 revenue of $138-140 million, representing 16%-18% year-over-year growth and exceeding the consensus forecast of $132 million. Analyst Lu Li maintained a positive outlook after Veracyte's Q4 testing revenue surpassed expectations, driven primarily by higher average selling prices and prior-period collections rather than volume growth. The company's 2026 testing revenue projections exceeded street expectations whilst maintaining a projected adjusted EBITDA margin of 25%, up from approximately 21% in 2024. UBS noted potential gains from new product contributions, suggesting current revenue projections don't fully account for all growth prospects. Veracyte develops diagnostic tests for thyroid, lung and other cancers, as well as autoimmune diseases.
Veracyte details upcoming MRD test, touts whole-transcriptome sequencing assay launches at JPM. NEW YORK - Veracyte on Thursday provided some guidance on its plans to launch a minimal residual disease (MRD) test at the JP Morgan Healthcare Conference. Get the full story with 360dx premium.