Clinical Quality Assurance Associate Director #2871
Menlo Park, CA, USA
Posted on Wednesday, March 1, 2023
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.
Grail’s Clinical Compliance department is seeking a clinical compliance expert to support the ethical and compliant conduct of Grail’s clinical studies. The Associate Director will work cross-functionally to manage Grail’s Clinical Quality Management System to help ensure that Grail’s clinical trials are conducted in accordance with Good Clinical Practice (GCP) standards and regulatory requirements.
- Revise, develop, and maintain Clinical Quality Management System procedures through a proactive knowledge management framework that incorporates learnings from internal and external inspections and compliance trends
- Participate in the creation of training materials and delivery of training designed to ensure that compliance requirements are understood and implemented
- Provide compliance advice in the review of SOPs related to clinical trial conduct, ensuring they are complete, consistent and compliant with applicable laws, regulations, and standards
- Help define, collect, and report compliance-related metrics
- Manage inspection readiness framework focused on clinical study team preparedness, partnering with cross functional leadership to establish inspection “norms” and processes
- Lead Inspection Readiness and Strategy support for teams prior to anticipated global and regional regulatory inspections (BIMO, pre-approval, GCP inspections, etc.)
- Support risk assessment and mitigation processes for clinical trials
- Provide day to day clinical compliance support for one or more studies to ensure compliance of clinical trial sites and processes against ICH E6 (GCP) and applicable regulations
To be successful in this role you will have:
- B.S./B.A. in a science or related life science field; advanced scientific degree preferred.
- 8+ years experience in any of the following industries: direct In Vitro Diagnostic, medical device or biopharma industry.
- Experience supporting complex regulatory inspections
- Expert knowledge of applicable regulations and standards as they relate to clinical trial conduct
- Significant experience managing quality activities such as conducting internal process and clinical laboratory audits, hosting or supporting regulatory inspections, managing CAPAs, etc.
- Demonstrated ability to initiate process improvement and take initiative
- Strong influencing skills, with the ability to work collaboratively and cross functionally, within a constantly evolving fast-paced startup environment
- Ability to drive and manage change with a positive approach
- Potential travel of up to 10%
Nice to have;
- Understanding of appropriate global medical device/IVD requirements, such as: ICH E6 (GCP), European Union (ISO 20916, ISO 14155, ISO13485:2016, IVDD/IVDR), US [21 CFR Part 812], etc.
The expected, full-time, annual base pay scale for this position is $154,000 - $205,000. Actual base pay will consider skills, experience, and location.
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.
Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.
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