Supervisor, Document Control

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, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. Essential Duties and Responsibilities: Lead and supervise the Document Control Team to assign tasks, provide training/guidance, monitor performance and workload. Provide coaching, development, training, and guidance to ensure compliance with document control and records management procedures. Develop, implement, maintain and continuously improve document control procedures, workflows, and training administration within the eQMS. Ensure controlled documents follow proper review/approval and revision practices, version control, distribution, and accessibility. Responsible to ensure Biennial Review of controlled document are completed in accordance to FDA QSR, ISO 13485, CAP, CLIA and internal quality policies. Responsible for the day-to-day operations of document control department for all controlled documents within the eQMS and the document control file room by routing/approving documents, archival/destruction of documents in the file room, and training administration within the eQMS according to company’s procedures. Ensure all document, records management, and training administration activities comply with FDA QSR, ISO 13485, and internal quality policies. Coordinate archival and offsite storage of documents according to retention schedules to ensure secure transfer and logging, and retrieval processes. Maintain a master inventory of all Control of Records in the file room. Independently identify and troubleshoot high complexity problems for document control and provide solutions. Develop and maintain SOPs related to document control, record retention, archival, and file room operations. Track and report document control metrics required for management review, audit readiness, operational tracking, and continuous improvement programs to report to senior management. Assist in reviewing and approving quality records as assigned including but not limited to: Manufacturing, Quality Control, Equipment, process monitoring, internal audits, and reports to ensure quality, safety and compliance of Guardant Health’s products. Implement change as needed at the direction of management. Create, review, and improve standard operating procedures / other QMS documentation as needed Represent Quality at cross functional meetings to provide guidance and ensure alignment with organizational quality standards, regulatory requirements, and process improvement initiatives Ensure procedures and processes are in place that lead to the delivery of quality results and continually assess their effectiveness to drive continual improvement Responsible for leading/supporting the development, implementation, and continual improvement of the Quality processes (e.g. document control, records control, and training) Ensure integrity of quality processes are maintained when changes are implemented. Provide training to members of the Document Control, Quality, and across departments on quality processes, compliance requirements, and best practices. Create and maintain quality metrics required for management review, audit readiness, operational tracking, and continuous improvement programs to report to senior management Support internal and external audits as necessary to provide requested documentation in a timely manner Escalate any issues or concerns with regard to deliverables and work capacity to management promptly Report all concerns of quality and/or safety to the Supervisor or Safety Officer Execute special projects and duties as assigned by department manager in a timely manner Qualifications B.S. degree in a scientific discipline or equivalent 5-8 years of document control experience in a medical device or regulated environment including 3 years in a supervisory role Certification in Continuous Improvement methodologies (e.g. Lean, Six Sigma, or equivalent) preferred Strong understanding of FDA 21 CFR Part 820, ISO 13485, 21 CFR Part 11, and document control best practices in a regulated Molecular laboratory Experience with electronic document management systems (e.g. MasterControl, Veeva, Propel, or equivalent) Experience with physical records management, archival, and offsite storage programs Experience validating eQMS software systems and implementing electronic workflows Excellent leadership, organization, communication, and problem solving skills 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 High degree of initiative and self-motivation Experience with Microsoft Office suite and Internet for business use 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. The annualized base salary ranges for the primary location and any additional locations are listed below. This range does not include benefits or, if applicable, bonus, commission, or equity. Each candidate’s compensation offer will be based on multiple factors including, but not limited to, geography, experience, education, job-related skills, job duties, and business need. Primary Location: Redwood City, CA Primary Location Base Pay Range: $116,200 - $159,800 Other US Location(s) Base Pay Range: $98,800 - $135,850 If the role is performed in Colorado, the pay range for this job is: $104,600 - $143,850 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. Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to Peopleteam@guardanthealth.com A background screening including criminal history is required for this role. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952). 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/ If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our Work Experience is the combination of everything that's unique about us: our culture, our core values, our company meetings, our commitment to sustainability, our recognition programs, but most importantly, it's our people. Our employees are self-disciplined, hard working, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they make us the #1 Top Workplace in the area.

Salary : $98,800 - $135,850