Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Job Description

Staff Clinical Quality Specialist

As a member of the Regulatory and Quality team at Guardant Health, the Staff Clinical Quality Specialist will play an integral role in the development and implementation of Clinical Quality support activities and philosophies across Guardant Health (e.g., Quality Systems, Clinical Trial Operations, Outcomes and Evidence, etc.). The Staff Clinical Quality Specialist will work cross-functionally to ensure compliance with the quality system and regulatory requirements. This position is involved with streamlining processes, ensuring quality system compliance, and meeting project deliverables. Given the wide variety of tasks involved in this position, the individual must demonstrate the ability to collaborate with other departments, analyze complex issues and identify opportunities for continual improvement.

Essential Duties and Responsibilities:

Leads the development, deployment, and maintenance of the global Clinical Quality program, including processes, tools, templates, and training.
Develops and executes Clinical Quality strategies (e.g., monitoring, auditing) to ensure data integrity, regulatory compliance, and high-quality outcomes.
Drives continuous improvement and process streamlining; identifies regulatory changes and maintains compliance gap analyses.
Authors, reviews, and updates controlled documents (e.g., SOPs) and provides recommendations to enhance the Quality Management System (QMS).
Provides training and guidance on QMS activities, supporting cross-functional teams and promoting informed clinical quality decision-making.
Participates in audits and inspections, and supports responses to findings.
Monitors quality processes, investigates non-conformances, manages CAPAs and complaints, and reports quality or safety concerns.
Develops quality metrics and independently resolves complex quality-related issues.
Executes special projects as assigned.

Qualifications

Qualifications:

B.S. degree in a Science or Engineering discipline.
Experience in Clinical, Investigational, and outcomes based settings.
8+ years experience in Life Science Industry (e.g. medical device, pharmaceutical or biopharmaceutical) in the Quality and Regulatory environment.
Proven experience related to Investigational Device Exemption (IDE), Good Clinical Laboratory Practice (GCLP), and Clinical Laboratory Improvement Amendments (CLIA) requirements.
Strong working knowledge of current Good Manufacturing Practices (cGMPs), Quality System Regulations, ISO 13485, ISO 14971 regulations.
Experience in compliance with quality standards in a regulated Molecular Diagnostics laboratory, and Laboratory Workflows preferred.
Experience with risk management and ability to utilize risk-based approaches to prioritize and take appropriate actions.

Work Environment:

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Additional Information

Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

The US base salary range for this full-time position is $109,310 to $150,320. The range does not include benefits, and if applicable, bonus, commission, or equity. The range displayed reflects the minimum and maximum target for new hire salaries across all US locations for the posted role with the exception of any locations specifically referenced below (if any).

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $128,600 to $176,850. The range does not include benefits, and if applicable, bonus, commission, or equity.

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [email protected]

A background screening including criminal history is required for this role. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952).

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.

Please visit our career page at: http://www.guardanthealth.com/jobs/

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