Director, Quality Programs and External Partnerships #2899

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.

As a key member of the Quality Leadership Team (QLT), the  Director, Quality PMO and External Partnerships will provide leadership on cross-platform initiatives, develop and implement quality strategy for external partnership efforts and work with key functional stakeholders to lead regulatory certification and accreditation efforts within GRAIL. 
You will;

• Provide Quality functional program leadership to drive GRAIL’s global accreditation and certification efforts, develop and manage future Quality strategy and work in partnership with functional stakeholders to achieve accreditation and certification objectives
• Provide Quality leadership, develop and implement the quality strategy and work in partnership with functional stakeholders to guide the development, regulatory approval, and commercialization activities in the delivery of companion diagnostic (CDx) projects within GRAIL.
• Partner with cross-functional team and Quality team to develop and implement Standards and Procedures fit for purpose quality systems that supports CDx and other external partnerships.
• Ensure adequate alignment with overall GRAIL Quality and Compliance policies and support effective collaboration with the relevant line functions and decision makers. 
• Ensures adequate execution and quality oversight of programs necessary for global registration and commercialization of partnership programs.
• Develop an operational Quality platform that can support future partnership activities at the global level and ensure proactive representation of QA with strategic project teams 
• Drive a culture of solution oriented and evidence-based mind-set with openness for innovative ways of working and new technologies. Implementing strategic and tactical plans to drive sustainable improvement. 
• Ability to exercise influence at the senior leadership and/ or executive level wherever partnership programs impacting Quality Management Systems are being discussed.
• Supports Regulatory Affairs in providing quality content and review of content supporting regulatory submissions to Health authorities globally.
• Lead and/ or support compilation, articulation of corrective actions, facilitation of metrics, and ensure adequate oversight of resolution of quality issues.

Your background should include;

• Minimum of a Bachelor and/or advanced degree in a life science discipline
• Minimum of 10 years experience in quality management systems in the FDA regulated domain - IVDs or medical device
• Experience with worldwide regulatory submissions and approvals in the area of in vitro diagnostics (IVD) Class III (PMAs), preferably Companion Diagnostics and Molecular Technologies
• Experience with implementation and execution for large-scale QMS accreditation and certification programs (i.e. ISO 13485, ISO 15189, etc), and leading the development of  new quality policies and procedures.
• A strategic thinker, with the capability to interact cross divisional and manage day-to day- operations of the group through leadership and effective interaction/influential skills
• We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

The expected, full-time, annual base pay scale for this position is $176,000 - $253,000. Actual base pay will consider skills, experience, and location. 

Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.

In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.

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. GRAIL maintains a drug-free workplace.


Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. 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 for consideration by GRAIL.