At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte enables our employees to not only make a meaningful impact on the lives of patients, but to also learn and grow within a purpose driven environment. This is what we call the Veracyte way – it’s about how we work together, guided by our values, to give clinicians the insights they need to help patients make life-changing decisions.
Our Values:
- We Seek A Better Way: We innovate boldly, learn from our setbacks, and are resilient in our pursuit to transform cancer care
- We Make It Happen: We act with urgency, commit to quality, and bring fun to our hard work
- We Are Stronger Together: We collaborate openly, seek to understand, and celebrate our wins
- We Care Deeply: We embrace our differences, do the right thing, and encourage each other
As the Quality Manager, Supplier QA you will lead the qualification, monitoring, and oversight of Veracyte’s Contract Manufacturers (CMOs) and IVD suppliers. You will serve as the primary quality interface between Veracyte and its external manufacturing partners, ensuring that all products and processes meet applicable regulatory requirements (e.g., ISO 13485, FDA QSR, IVDR) and internal quality standards. The ideal candidate brings strong supplier quality experience, auditing, and managing external manufacturing relationships. This is a hybrid role (remote and in office up to 3 days a week as necessary) and is based out of our headquarters in South San Francisco (SSF), California, United States. For the right candidate, we will consider someone remote.
Responsibilities:
- Own and lead the Supplier Quality Management to ensure vendor products, processes and services are provided in compliance with applicable regulations (e.g., FDA, ISO 13485, EU IVDR, etc.) and Veracyte’s quality standards.
- Establish and maintain supplier and CMO oversight strategies, including risk-based qualification, periodic performance monitoring, and quality metrics.
- Serve as the primary Quality lead for supplier and CMO relationships, providing quality input during supplier selection, qualification, and issue resolution.
- Lead and execute supplier audits, ensure timely closure of audit findings, and drive continuous improvement across the supplier base.
- Develop, implement, and maintain supplier quality metrics and monitoring programs.
- Lead investigations of supplier and CMO related quality incidents, perform root cause analysis, assess impact on product or regulatory compliance
- Oversee and maintain the Approved Supplier List (ASL) and associated supplier documentation in compliance with ISO 13485 and IVDR.
- 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 product quality and regulatory compliance.
- Ensure appropriate validation and verification activities are performed for supplier-initiated changes
- Collaborate cross-functionally with R&D, Regulatory Affairs, and Supply Chain to support new product introductions and design transfers to CMOs.
- Support regulatory inspections and notified body audits, serving as the SME for supplier quality.
- Champion continuous improvement initiatives to strengthen supplier quality processes and reduce external quality risk.
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field
- A minimum of 6 - 7 years of progressive experience in Quality Assurance within the medical device or IVD industry.
- In‑depth working knowledge of in‑vitro diagnostic device quality requirements, including ISO 13485:2016, IVDR (EU 2017/746) and, ISO 14971:2019 risk management
- Prior experience in implementing and establishing a Supplier Quality program that is compliant to ISO13485 and IVDR requirements
- Demonstrated success in supplier quality leadership, audit execution, and external manufacturing oversight.
- 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
For candidates based in our San Diego office, the salary range is $129,000-$142,000
For candidates based in our South San Francisco office, the salary range is $142,000-$162,000
For candidates working remote (US), the salary or hourly range is $123,000-$139,000
#LI-Hybrid #LI-Remote
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to years of experience, skillset, geographic location, industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives, and restricted stock units.
What We Can Offer You
Veracyte is a growing company that offers significant career opportunities if you are curious, driven, patient-oriented and aspire to help us build a great company. We offer competitive compensation and benefits, and are committed to fostering an inclusive workforce, where diverse backgrounds are represented, engaged, and empowered to drive innovative ideas and decisions. We are thrilled to be recognized as a 2024 Certified™ Great Place to Work® in both the US and Israel - a testament to our dynamic, inclusive, and inspiring workplace where passion meets purpose.
About Veracyte
Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for our tests, along with new insights to support continued innovation and pipeline development. For more information, please visit www.veracyte.com or follow us on LinkedIn or X (Twitter).
Veracyte, Inc. is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status. Veracyte participates in E-Verify in the United States. View our CCPA Disclosure Notice.
If you receive any suspicious alerts or communications through LinkedIn or other online job sites for any position at Veracyte, please exercise caution and promptly report any concerns to [email protected]
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