Clinical Audit Program Manager

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

The Clinical Audit Program Manager plays an integral role on the Quality team and supports the company's compliance activities with the FDA Quality System Regulation, ICH/GCP, GxP, ISO 13485 as well as CLIA, CAP, and applicable state requirements. The Clinical Audit Program Manager works closely with a wide variety of departments to support quality activities and identify opportunities for continual improvement.

Essential Duties and Responsibilities:

• Responsible for implementation and maintenance of the global Clinical Audit program, comprising but not limited to clinical vendor audits, clinical site audits, and biopharma clinical study audits.
• Functions as a lead auditor and performs audit support to ensure compliance across Regulatory and applicable internal processes (i.e., SOPs, etc.).
• Provide recommendations for continuous improvement to strengthen the internal quality 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.
• Execute special projects as assigned.
• Report and document all concerns of test quality and/or safety to Quality Management, or Safety Officer, as applicable.
• Ability to travel up to 30 -40%.

Qualifications

• B.S. degree in a scientific  discipline.
• 6-8 years of experience in the Life Sciences Industry, preferably in IVD regulated environment.
• Strong working knowledge of FDA QSR, GCP, GCLP, ICH regulations.
• Lead auditor certification/qualification preferred.
• Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments.
• Ability to work effectively in a team environment and build strong working relationships.
• Ability to successfully balance and prioritize multiple ongoing projects/tasks in a dynamic environment.
• Ability to identify, analyze and solve problems with minimal direction and escalate concerns to management.
• Proven attention to detail and accuracy.
• Effective organizational skills.

#LI-AH1

#LI-Hybrid

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 $75,000 to $116,000. 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 $108,000 to $145,000. 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 relev