Quality Director, Companion Diagnostics

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. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

As a key member of the Quality Leadership Team, the Quality Director , Companion Diagnostics will Provide Quality leadership, develop and implement quality strategy and work in partnership with key functional partners to support development, regulatory approval, and commercialization activities, in the delivery of Companion Diagnostic (CDx) projects within GRAIL.

You will:

• Provide QA leadership, develop and implement the quality strategy and work in partnership with CDx partners to support development, regulatory approval, and commercialization activities, in the delivery of companion diagnostic (CDx) projects within GRAIL.
• Collaborate closely effectively with Head of CDx Medical Function to ensure end to end oversight of Quality operational and technical activities impacting teams activities are assessed, reviewed and issues mitigated as appropriate.
• 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 vital for global registration and commercialization of CDx.
• Develop a QA structure that could support CDx activities at the global level and ensure proactive representation of QA at strategic project teams and accurate cross-functional takeaways and interactions from CDx assay development through CDx approval and launch.
• 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 CDx programs impacting Quality Management Systems are being discussed.
• Provides QA leadership/mentorship as deemed vital for CDx assay development, validation, patient enrollment, sample analysis activities, and collection and/or review of regulatory documents.
• Supports Regulatory Affairs in providing quality content and review of documents supporting CDx 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 field
• 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 within QMS implementation, and developing new quality policies and procedures.
• A strategic problem solver, with the capability to interact cross divisional and manage day-to day- operations of the group through leadership and effective interaction/influential skills
• Must be able to work in a biohazard environment and follow safety policies and standards outlined in the Safety Manual

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.

GRAIL, Inc. and its affiliates and subsidiaries ("GRAIL") does not accept any liability for fees for resumes from recruiters or employment agencies ("Agency"), without a binding, written recruitment agreement between GRAIL and Agency describing the services and specific job openings ("Agreement"). GRAIL may consider any candidate for whom an Agency has submitted an unsolicited resume and explicitly reserves the right to hire those candidate(s) without any financial obligation to the Agency, unless an Agreement is in place. Any email or verbal contacts with any person within GRAIL is inadequate to create a binding agreement. Agencies without an Agreement are requested not to contact any hiring managers of GRAIL with recruiting inquiries or resumes. Agencies interested in partnering with GRAIL may contact GRAIL's HR Department through our Customer Service team .