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.
The post design transfer risk management is a requirement for a successful FDA Pre-Market Approval Inspection (PAI) to support our PMA submission, as well as to achieve and maintain IVDR certification in the European Union. This role is assigned sole responsibility for post-transfer total product life cycle risk management for the Galleri Assay and the accessory Specimen Collection Kit.
Responsibilities:
- Lead the maintenance of post Design Transfer Risk Management Files, and support the development of pre-Design Transfer RMFs, ensuring alignment with IVDR, ISO 13485, 21 CFR 820, and ISO 14971.
- Develop/lead all aspects of the associated FMEAs - use, design, process and other risk assessment processes and documentation (as required).
- Provide comprehensive risk management summaries for Post Market Surveillance Reports and Periodic Safety Update Reports in compliance with IVDR requirements.
- Work effectively with multiple functions (R&D, MSAT/QC, Clinical Laboratory Operations, Product/Program, Regulatory, Supply Chain, Medical, Engineering Operations, etc.) to ensure teams understand and implement risk management principles throughout the product life cycle.
- Provide guidance to other departments and serve as subject matter expert (SME) on applicable regulations and standards.
- Support the Quality, Regulatory, and Compliance functions ensuring a unified QA/RA/Compliance commitment to achieving established goals and objectives.
- Represent Quality Operations on sanctioned cross-functional projects driving toward effective, on-time completion of business goals and objectives.
- Drive a culture of quality across the organization with the goals of efficiency, compliance, and continual improvement.
- Support high quality audit and inspection planning, execution, and follow-up by serving as a Subject Matter Expert (SME) in the front and back rooms.
Preferred Qualifications:
- Bachelor’s degree in science, engineering, or other technical area.
- 5 + years of experience working within a medical device, pharmaceutical, or
- biotech quality management system risk management program.
- Experience working with in vitro diagnostic medical device regulations and standards including ISO 13485, ISO 14971, 21 CFR 820, IVDR, and other applicable industry requirements.
- Experience supporting design transfer activities and product risk management.
- Excellent written and verbal communication skills.
- Ability to comprehend and interpret technical information.
- Master’s degree in a related technical area, or MBA a plus
- Next Generation Sequencing (NGS) experience a plus
- Clinical laboratory QMS experience including ISO 15189, 21 CFR Part 493 (CLIA), CAP, New York State Department of Health (NYSDOH) a plus
- ASQ Certified Quality Auditor, Certified Quality Engineer, or similar a plus
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.
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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.
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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.
