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.

The Quality Manager, Operations will be the key liaison from quality with both the internal reagent manufacturing operations as well as with external Contract Manufacturing Organizations (CMOs). This individual will also be responsible for Quality oversight of technical transfers. This individual will be responsible for Current Good Manufacturing Practices (cGMPs), GCP, ISO 13485:2016, CLIA, CAP, and New York State are implemented and followed within reagent manufacturing and tech transfer.

You Will:

• Quality oversight of contract manufacturing operations for both commercial and clinical trial materials. Includes review and approval of change control requests, deviations, and investigations.
• Oversee and monitor Quality processes to ensure operations are adequately defined and that GMPs are utilized for the manufacture of reagents internally and at CMOs.
• Review and guide process validation and test method validation plans and protocols, executed protocols, and summary reports at both GRAIL and CMOs.
• Performs technical assessments and Quality approval of deviations, incident reports, nonconformances, CAPAs and investigations for commercial and clinical products.
• Participate in risk assessment and / or Failure Mode and Effects Analysis activities for both design and process FMEAs.
• Define and implement, as appropriate, quality standards, systems, and metrics for commercial operations.
• Compile, organize, and present metrics for areas of responsibility to senior management.
• Participate in preparation for and execution of regulatory audits. Ensures audit observations are addressed appropriately and completed on schedule.
• Manage review of product release and data, Quality lead for method transfers and validations.
• Provide and / or lead quality support on tech transfers and GXP investigations.
• Support Quality Management Reviews and periodic product reviews
• Support the development, implementation, and revision of corporate quality systems.
• Participate in continuous improvement strategy which aligns to the business strategy and operational strategy while taking into account present operational realities.

Your Background Should Include:

• BA/BS and a minimum of 7 years in Quality Assurance.
• Minimum of 5 years in Quality Operations at an FDA-regulated medical device or pharmaceutical company.
• Minimum of 3 years of people management experience
• Proven experience in Change Control, CAPAs, CMO management, and tech transfer.
• Demonstrated success engaging teams and stakeholders for collaboration in advancing quality operations outcomes in business and quality leadership.
• Experience with managing contract manufacturing and/or testing organizations, including quality agreement negotiation.
• Ability to intake and process large quantities of information and subsequently make concise and timely decisions.
• Ability to communicate above and below level in a way that fosters positive relationship building.
• Proven knowledge of GxP regulations, quality systems, and regulatory guidance documents in the US and EU.
• Demonstrated flexibility and advancement within a fast-paced environment.
• Demonstrated project management skills.
• Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view.
• Excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities.

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.