11 days old

Risk Management Program Lead

Guardant Health
Redwood City, California 94063
  • Job Status
    Full Time

Company 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.

Job Description

As a member of the Regulatory and Quality Leadership team at Guardant Health, the Risk Management Program Lead will play an integral role in the development and implementation of risk-based programs and philosophies across Guardant Health (e.g., Quality Systems, Operational Systems, Development Systems, etc.). The Risk Management Program Lead will work cross-functionally to be a driver for streamlined, risk-based, scalable, and sustainable systems and programs which will enable growth at Guardant Health. This role must be able to work across boundaries and a variety of organizational roles to accomplish these tasks.

Essential Duties and Responsibilities:

  • Responsible for successful development, deployment and maintenance of a global risk management program, including business processes, tools, templates and training
  • Responsible for both Enterprise Risk Management and Quality Risk Management programs
  • Ensure development of solutions to complex quality and enterprise level risks that may potentially impact the goals and objectives of the organization in regards to product quality, patient safety, regulatory compliance or right to operate.
  • Responsible for creating, communicating and coordinating procedures and tactics which improve risk-based decision making and associated processes
  • Responsible for the establishment and governance of Quality Policy and Standards for Enterprise Risk Management and Quality Risk Management
  • Lead cross-functional Risk Management implementation and complex risk-based initiatives as the primary change agent, partnering with customers, leading internal efforts within the team, communicating/coordinating/bringing together key stakeholders, resolving conflicts, and driving value-added risk-based processes, decisions and practices
  • Provide leadership/facilitation of complex risk processes across the corporation. Communicate regularly with decision-makers to enable and support effective risk-based decision-making
  • Integrate risk management into routine operations and in the Quality System. Provide recommendations for continuous improvement to strengthen internal processes and systems
  • Create and maintain quality metrics required for management review
  • Develop, mentor and train personnel and internal customers on risk management application, tools and processes. Provide guidance, and support the company for other QMS related activities
  • 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.

 Competencies

  • Collaborative Leadership - Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to alignment. Ability to foster effective inter-departmental and cross-functional partnerships. High tolerance for ambiguity, able to create order from chaos.
  • Ownership and Accountability - Takes accountability for actions, drives results, learns from mistakes. Is direct and truthful and therefore widely trusted - delivers on promises, goals, and expectations. Makes quality decisions and resolves problems rapidly. Asks "what can I do to help?".
  • Decision Making - Ability to make sound decisions on quality related subjects, scheduling, allocation of resources, and managing priorities
  • Communication - Ability to communicate effectively (verbal and written) up and down, across all levels of the organization throughout various deparments; present complex and/or new ideas with clarity and simplicity.
  • Planning/Organization - Excellent planning and prioritization skills with the ability to multi-task and adapt. Successfully balances and prioritizes multiple ongoing projects/tasks in a fast-paced, deadline driven environment. Able to synthesize large amount of information. Able to deliver results despite shifting environment.
  • Analytical Problem Solving - Ability to identify problems, define problem statement clearly and accurately, and apply structured and disciplined methodology to identify data-driven root causes. Innovative and effective in solution development, risk mitigation, and execution.
  • Customer focused - Partners with customers, looks ahead to predict future customer needs. Manages expectations.

Requirements

  • B.S. degree in a Science or Engineering discipline
  • Experience in leading both Enterprise and Quality Risk Management programs
  • A minimum of 8 years of experience in Life Science Industry (e.g. medical device, pharmaceutical or biopharmaceutical) in the Quality and Regulatory environment
  • Strong working knowledge of cGMPs, Quality System Regulations, ISO 13485, ISO 14971 regulations.
  • Experience in compliance with quality standards in a regulated Molecular laboratory preferred
  • Experience with risk management and ability to utilize risk-based approaches to prioritize and take appropriate actions
  • Experience with application of proven process improvement tools and methodologies such as: LEAN/Six Sigma especially in areas of Supply Chain Management/Manufacturing/Engineering or Process Development highly preferred.

Additional Information

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 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.

Categories

Posted: 2021-01-06 Expires: 2021-02-07

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Risk Management Program Lead

Guardant Health
Redwood City, California 94063

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