GRAIL

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured.

Raleigh-Durham, NC

Hybrid

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Jobs//Hybrid//Raleigh-Durham, NC//Developer + Engineer//

Director, Manufacturing Quality Operations # 3074 (Raleigh, NC)

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Employer Provided Salary: $107,000-$142,000 Annually

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.

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Joerg Bredno

Principal Scientist, Computational Biology and Interpretation

WIDEN YOUR SCOPE

A huge data set with an even bigger impact

“Cancer is a nasty, diverse disease that can affect widely different regions in the genome,” Principal Scientist Joerg Bredno said, and understanding how and why cells change isn’t easy. Luckily, his team works with more than 12 petabytes of molecular data — which translates to more than 1 million gigabytes — and a high-performance scientific computing environment that can handle analysis at that scale. With these tools, Bredno’s team is building an even larger training data set for the next generation of GRAIL’s early detection, multi-cancer screening test, slated to roll out this year.

It is rewarding that we can see, learn and share relevant insights from our data that so far doesn't exist anywhere else in the world in this form.

Ting Ma

Associate Director, Data Engineering

ACCELERATE TOGETHER

A team united by passion, fueled by collaboration

GRAIL’s team sets lofty goals for its products, which require the unique talents and perspectives of every employee. Take one eight-month study that Associate Director Ting Ma worked on, parsing data from a GRAIL-sponsored clinical trial. Due to the volume of data, teamwork was imperative to define and implement clinical features, refine codes with robust test cases and tweak them as continuous feedback rolled in. The work is important, but that's not the only plus: “Cross-functional team collaboration is fun,” Ma said. “You get to learn so much while contributing to each project.”

GRAIL is taking on a challenge that is unprecedented. It can only become successful when people with different expertise collaborate deeply.

Ying Luan

Associate Biostatistical Director

UNCOVER NEW OPPORTUNITIES

Sharp talent, perpetually looking to learn more

There’s a reason top talent, like Associate Biostatistical Director Ying Luan, joins GRAIL. “Here, I knew I could have the opportunity to contribute to the development of innovative analysis methodologies,” Luan said. She’s now working on a diagnostic aid project, planning and designing validation for clinical studies. It’s a new area for her, but there’s plenty of support for learning new skills at the company: With resources like LinkedIn Learning, workshops and conferences, she finds footing in the field, while diversity and inclusion trainings connect her fully to GRAIL’s culture.

Post-launch activities and payer’s reimbursement were new to me when I joined GRAIL. But now, I’m learning new things on a daily basis with different stakeholders in mind.

What are GRAIL Perks + Benefits

GRAIL Benefits Overview

We’re committed to creating the best experience for everyone at GRAIL, ensuring that each member of our team has comprehensive benefits and resources to thrive at all stages of life, both at work and at home.

Culture

Volunteer in local community

Partners with nonprofits

Intermountain Healthcare

Open door policy

OKR operational model

Team based strategic planning

Open office floor plan

Employee resource groups

Employee-led culture committees

Hybrid work model

In-person all-hands meetings