Full Job Description
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood 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 launched liquid biopsy-based Guardant360®, Guardant360 CDx and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.
As a member of the Regulatory and Quality Leadership team the Director of the Global Audit program plays an integral role in supporting both the Regulatory Affairs and Quality teams, and the overall global compliance activities for Guardant Health (e.g., FDA Quality System Regulation, ISO 13485 as well as CLIA, CAP, and applicable state requirements). The Director Global Audit Program works cross-functionally to create a successful program which would include but not be limited to, Internal, External (Partner), Supplier, Regulatory Body, and Clinical Audits. Additionally, this role will have responsibly to work cross functionally to assure all appropriate certifications, accreditations, and licenses are maintained globally. This role must be able to work across boundaries and a variety of organization roles to accomplish these tasks.
Essential Duties and Responsibilities:
Will be a valued member of the Regulatory and Quality (R&Q) leadership team
Responsible for implementation and maintenance of the global audit program
Responsible for creating, communicating and coordinating annual audit schedules for each of the areas under this responsibility
Responsible to be the in-room audit manager for all regulatory and external audits.
Can function as a lead auditor for internal audits and perform audits to ensure compliance to internal and external requirements.
Will provide recommendations for continuous improvement to strengthen the internal processes and structure
Responsible for the overall audit processes and assuring consistency across the audit program
Responsible for the development and training of a cross functional audit cadre to execute and complete appropriate audit activities.
Create and maintain quality metrics required for management review
Provide training, guidance, and support the company for other QMS related activities
Support routine Quality processes such as investigating non-conformances, CAPAs, complaints, other process monitoring activities
Ability to independently develop solutions for complex problems
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 the Supervisor or Safety Officer, as applicable.
B.S. degree in a scientific discipline
Proven leadership in Life Science Industry in the Quality and Regulatory environment
Strong working knowledge of FDA QSR, ISO 13485, ISO 14971 regulations
Experience in compliance with quality standards in a regulated Molecular laboratory preferred
Certified ISO 13485 lead auditor preferred
Ability to utilize Risk Based approaches to prioritize and take appropriate actions
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 fast-paced, deadline driven environment
Ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
Proven attention to detail and accuracy
Effective organizational skillls
Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment. Ability to sit for extended periods of time.
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.
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