Job Description

THE MANAGER, QUALITY OPERATIONS will lead a team that is responsible for overseeing quality operational support for our products and ensuring compliance with applicable regulatory and industry standards. This role will drive efficiency in procedures and practices for the Laboratory and identify opportunities for continual improvement.

 ESSENTIAL DUTIES AND RESPONSIBILITIES:

•  Responsible for quality activities as it relates to reagent manufacturing, including in-process and final inspection and ensure GMP are followed
• Ensuring that equipment and facilities are adequately validated/qualified
• Responsible for the supplier management program
• Responsible for product monitoring, metrics development and trending analysis on a routine basis by identifying, generating and publishing quality metrics and reports related to the performance and report anomalies to management
• Assess and revise processes as needed and identify opportunities to streamline systems and processes
• Participate in inspection readiness activities and during regulatory inspections
• Provide support for processes such as Material Review, Change Control
• Represent Quality at cross functional meetings, as required
• Support other routine Quality processes such as investigations, equipment qualifications, as required
• Ensure that all policies, procedures, and records are reviewed and approved
• Execute special projects as assigned
• Report and document all concern of test quality and/or safety to the Supervisor or Safety Officer, as applicable

Qualifications

• B.S. degree in a scientific discipline (e.g. biology, chemistry, or related field)
• 8-10 years of quality experience in a biotechnology, and/or medical device industry  with GMP experience. Molecular laboratory experience preferred
• 5+ years of quality experience in a FDA/ISO regulated environment
• Experience in overseeing quality processes such as supplier quality, acceptance, equipment validations
• Effective verbal and written communication skills and ability to share and receive information from all levels of the organization
• 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
• High degree of initiative and self-motivation
• Drive for results and continual improvement
• Experience with Microsoft Office suite and Internet for business use

Additional Information

Employee may be required to lift routine office supplies up to 20 lbs 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.

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.

To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our PRIVACY NOTICE FOR JOB APPLICANTS.

PLEASE VISIT OUR CAREER PAGE AT:  HTTP://WWW.GUARDANTHEALTH.COM/JOBS/

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