Global Audit Manager

Company Description

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 visitand follow the company onLinkedInX (Twitter)andFacebook.

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.

Essential Duties and 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 companys 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.

Qualifications:

• Typically requires a university degree and generally 8 years of related experience; 6 years and a Masters 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%.

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.

Hybrid Work Model: This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has 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.