GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

Summary:

As a key member of the GRAIL Companion Diagnostics (CDx) team, the Staff Quality Engineer, Companion Diagnostics will collaborate with internal teams and external partnerships to develop an operational framework to co-develop RUO and CDx programs and products. This includes guidance and execution of program strategies and the implementation of RUO and companion diagnostics from development through regulatory approvals. 

This position will provide Quality expertise and implement quality strategy, working in partnership with key functional stakeholders to support the development, regulatory approval and commercialization of products under the GRAIL Companion Diagnostic (CDx) platform. The ideal candidate will have demonstrated GCP experience and the ability to lead and drive improvements to a work culture committed to GRAIL values - Grit, Respect, Accountability, Integrity and Leadership.

You will:

• Strategize, scope and plan quality programs to best position GRAIL’s CDx products with pharma partners, FDA and/or health authorities.
• Partner with cross-functional team and Quality team to develop and implement Standards and Procedures fit for purpose quality systems that supports RUOs and CDx clinical operational programs
• Provide QA leadership, develop and implement the quality strategy and work in partnership with CDx stakeholders to support clinical operational execution, regulatory approval, and commercialization activities, in the delivery of companion diagnostic (CDx) projects within GRAIL.
• In collaboration with the CDx team, the individual will take a lead role to ensure that all relevant clinical trial operations and activities are compliant and meet regulatory expectations in a GCP environment.
• Interact with new potential pharma partners to develop business opportunities; educate and guide on joint standard methodologies and strategies. 
• Ensure adequate alignment with overall GRAIL Quality and Compliance policies and support effective collaboration with the relevant line functions and decision makers. 
• Take a lead role to ensure product safety by driving risk management activities including reviewing risk management plans, interfacing with vendors and facilitating system risk assessments.
• Ensures adequate execution and quality oversight of programs necessary for end to end lifecycle management beginning with CAP / CLIA application through global registration and commercialization of RUOs and CDx.
• Support the development and review of Standard Operating Procedures and policy guidelines for Quality interactions with key CDx partnerships.
• Supports Regulatory Affairs in providing quality content and review of documents supporting CDx submissions to Health authorities globally.
• Provide consultative and training support to the business teams and core team personnel related to product development strategies, design control, and co-development best practices.
• Perform other duties as required or assigned

Your qualifications and background will include:

• Minimum Qualifications
• B.S./B.A. in a science or related life science field; advanced degree preferred. Certification from ASQ and/or PMI preferred but not required
• Advanced scientific degree a plus




• Experience & Expertise:
• 8+ years of relevant experience, including 3+ years of Medical Device and/or IVD experienceComprehensive experience with design control and risk management
• Experience with Companion Diagnostics (CDx) partnerships/programs and product development
• Experience in diagnostics or biomarker development with emphasis on oncology a plus Pharma clinical/statistical/regulatory experience in oncology, immunology or related field a plus 




• Knowledge, Skills & Abilities: 
• Direct experience in the development of in vitro diagnostics, ideally within a companion diagnostics framework including working knowledge of the current and evolving global regulatory environment.
• Demonstrated knowledge of QSR regulations, GMP manufacturing, ISO13485, ISO 14971, and FDA and EU medical device regulationsUnderstanding of GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements
• Experience performing due diligence and auditing vendorsExperience performing and hosting due diligence activities, auditing and vendor management
• Knowledge and experience in validation in highly regulated manufacturing environments

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.