Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
GRAIL is headquartered in Menlo Park, California, 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 grail.com.
This individual will be responsible for establishing, implementing, maintaining, and improving GRAIL’s product labeling program and acts as technical lead supporting technical operation on process monitoring, troubleshooting and investigation. This person works closely with Regulatory, Quality, Supply Chain, R&D and Clinical Laboratory. The person in this role consistently applies critical thinking skills and good judgment to solve broad, complex problems, effectively establishing and cascading functional strategy and decisions across teams and communicating status and recommendations to executive management.
Key responsibilities include providing expertise and strategic oversight to 1) ensure GRAIL’s product labeling operations achieve and maintain compliance with the EU In Vitro Diagnostic Regulation (IVDR), ISO 13485, ISO 14971, ISO 15189, 21 CFR 820, 21 CFR 809, and related medical device regulations and 2) ensure technical operation is effectively, and timely identifying and containing Clinical Lab production issues by supporting process monitoring, troubleshooting and investigation.
Responsibilities:
- Ownership of efficient, effective, and compliant processes and their governing procedures for GRAIL’s product labeling.
- Assigns label part numbers to all device labeling.
- Establishes and maintains labeling specifications (printed and electronic).
- Establishes and maintains source artwork files adhering to labeling specifications.
- Ensures all label claims are substantiated through the Design History File in partnership with Regulatory and Design teams.
- Initiates and drives to completion Veeva change control workflows for labeling specifications, source artwork, and final labels initiation and change management.
- Represents the Labeling Program as Subject Matter Expert during audits and inspections
- Maintains and continually improves the Labeling Program to ensure state of the art labeling controls at GRAIL.
- Where applicable, acts as technical lead on process monitoring, troubleshooting and deeper investigations
Preferred Qualifications:
- Bachelor’s degree in a science, engineering, or other technical area.
- 12+ years of experience with medical device or pharmaceutical product labeling operations or NGS assays.
- Working knowledge of applicable medical device regulations and standards including but not limited to 21 CFR 809, 21 CFR 820, ISO 13485, ISO 14971, ISO 15189, MDR/IVDR.
- Proven leadership, organizational and management skills to drive effective, compliant cross-functional decision making.
- Excellent written and verbal communication skills and attention to detail.
- Ability to comprehend and interpret technical information related to GRAIL's product claims.
- Master’s degree in a related technical area, or MBA.
- Experience preparing for, leading, and supporting regulatory inspections/audits and effectively responding to findings.
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 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.
Top Skills
What the Team is Saying
.JPG)
.JPG)
What We Do
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is using the power of high-intensity 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 and commercialize pioneering products
Why Work With Us
Everything we do is guided by our mission to detect cancer early, when it can be cured. It’s the reason we’re here, and it’s no small task.
The right people make all the difference. That’s why we’re looking for those who strive to share their knowledge, contribute their skills, inspire each other and commit to something bigger than themselves.
Gallery
GRAIL Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
GRAIL has a variety of work types depending on the roles. Some are onsite like a lab role, others are hybrid and still others are remote. Hybrid is typically Tuesday and Thursday but leaders may be flexible depending on the role.
