Guardant Health · 11 hours ago
Global Audit Manager
Redwood City, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$140K/yr - $192K/yr
8+ years expGuardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. The Global Audit Manager is responsible for driving compliance with various regulatory standards and implementing global audit programs while ensuring robust quality practices across the organization.
BiotechnologyHealth CareHealth DiagnosticsOncologyTherapeutics
Responsibilities
Responsible for implementation and maintenance of the global audit programs, comprising but not limited to clinical vendor audits, clinical site audits, biopharma clinical study audits and internal quality audits
Functions as a lead auditor and performs audit support to ensure compliance across regulatory requirements and applicable integral processes (i.e. SOPs, etc.)
Provide recommendations for continuous improvement to strengthen the quality management system processes and structure
Documents audit findings and monitor corrective actions associated with the audit findings
Creates and maintains audit program metrics required for data analysis and management review
Develops and maintains procedures and records that demonstrate compliance to regulatory requirements and the company’s QMS
Provides training, guidance, and mentorship to audit teams, including cross-functional, as needed
Ensure processes are in place that lead to the delivery of quality results and continually assess their effectiveness to drive continual improvement
Assist with inspection readiness activities, as needed
Execute special projects as assigned
Report and document all concerns of test quality and/or safety to Quality Management, or Safety Officer, as applicable
Qualification
Required
Typically requires a university degree and generally 8 years of related experience; 6 years and a Master's degree; 3 years and a PhD; or PharmD/MD
Strong working knowledge of FDA QSR/QMSR, ISO 13485, GCP, GCLP, ICH regulations
Formal Lead auditor training required; lead auditor certification preferred
Strong verbal and written communication skills; able to collaborate across all organizational levels
Effective team player with ability to build strong relationships
Skilled at prioritizing and managing multiple projects in a dynamic environment
Proactive problem solver with minimal supervision; escalates issues appropriately
Detail-oriented with strong organizational skills
Ability to travel up to 40%
Preferred
Lead auditor certification preferred
Company
Guardant Health
Guardant Health is a precision oncology company that uses blood tests, data sets, and analytics to provide treatment to cancer patients.
1001-5000 employees
H1B Sponsorship
Guardant Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (38)
2024 (50)
2023 (40)
2022 (72)
2021 (57)
2020 (29)
Funding
Current Stage
Public CompanyTotal Funding
$2.53BKey Investors
Baillie GiffordSoftBank Vision FundOrbiMed
2025-11-05Post Ipo Equity· $284.4M
2025-11-05Post Ipo Debt· $350M
2023-12-21Post Ipo Equity· $90.7M
Leadership Team
AmirAli Talasaz
Co-founder and Co-Chief Executive Officer
Helmy Eltoukhy
Chairman and Co-Chief Executive Officer
Recent News
Medical Device Network
2026-01-20
2026-01-19
Company data provided by crunchbase