Director, Manufacturing Quality Operations # 3074

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.

This role leads GRAIL's Manufacturing Quality Operations, focusing on enhancing GRAIL's quality management system for manufacturing. It involves global Quality Assurance oversight, team management, and support for IVD, clinical trial, and LDT reagent manufacturing, as well as external specimen collection kit production. The position is an on site role, based at GRAIL’s RTP Durham, North Carolina facility with occasional travel to Menlo Park (Bay Area), CA.

You will:

• Direct GRAIL’s RTP and Menlo Park Manufacturing Quality Operations (MQO) teams.
• Ensure compliance with regulatory requirements (21 CFR 820, ISO 13485) at manufacturing and warehouse locations.
• Lead resolution of product quality issues, including deviations, NCRs, and CAPA workflows.
• Oversee Quality partnerships for equipment management, validation programs, and warehouse operations.
• Oversee Quality partnerships for IVD labeling compliance.
• Partner with Operations to ensure quality of products.
• Maintain communication on critical quality issues.
• Develop and execute quality strategies for business objectives.
• Monitor and report manufacturing quality data.
• Act as SME during audits/inspections.
• Ensure Device Master Record/Medical Device File compliance.
• Establish and implement Acceptance Activities processes including Receiving and Finished Product inspections.
• Control quality-related budget and costs.
• Interface with auditors and regulatory bodies.
• Collaborate with site leadership and support cross-functional projects.
• Promote a culture of quality and diversity.
• Lead, develop, and manage staff.

The required background and qualification will include:

• BS/BA degree + 12 years related experience, or Masters + 10 years, or PhD + 8 years within a medical device, pharmaceutical, or biotech quality management system.
• Extensive managerial experience with applicable regulations and standards (IVDR, 21 CFR 820, ISO 13485, ISO 14971, 21 CFR 11).Leadership, organizational, and regulatory inspection experience.
• Excellent verbal and written communication skills.
• Technical and regulatory comprehension.

The preferred background and qualification will include:

• Master’s degree or MBA.
• Next Generation Sequencing (NGS) experience.
• Clinical laboratory QMS experience (ISO 15189, CLIA,CAP, NYSDOH).

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.