Global Audit Manager

Guardant Health•Redwood City, CA

7d•Hybrid

About The Position

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 . The Global Audit Manager is a key member of the quality team, responsible for driving compliance with FDA QMSR, ICH GCP, ISO 13485, CLIA, CAP, and applicable state regulations. This role partners cross-functionally to ensure robust quality practices and proactively identifies opportunities for continuous improvement across the organization.

Requirements

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%.

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.