Title: GMP Auditor (Remote)
Location: Remote or Menlo Park, CA
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
The GCP Auditor will ensure the ethical and compliant conduct of GRAIL’s global clinical studies. Will lead all aspects of GCP (Good Clinical Practice) audits, ensuring regulatory inspection readiness, implementing GCP principles across diverse functional groups, managing clinical issues, and ensuring clinical trial related-SOP compliance.
You will be responsible:
- For GCP Auditing and Inspection Readiness
- Supporting inspection readiness training, conducting and coordinating mock BIMO inspections. Coordinate and participate in the BIMO sponsor inspection, and other regulatory agency sponsor inspections
- Independently planning, scheduling, and conducting audits to assure that clinical investigations comply with all applicable regulatory requirements such as ICH E6 (GCP) and GRAIL policies and procedures
- Conducting complex routine and for-cause clinical study sites and vendor audits, support process audits, and manage with minimum oversight
- Documenting audit observations; evaluates impact and makes recommendations for corrective actions. Evaluate responses to audit findings and ensure that appropriate corrective actions are completed
- Contributing to the development of audit procedures and processes. Keeps current on and interprets worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes
- Working with colleagues on cross-functional GxP audit plans as required
- For GCP Compliance
- Assessing compliance of GCP clinical trial sites and processes against ICH E6 (GCP) and applicable global regulations
- Maintaining GCP related clinical SOPs in compliance with all applicable regulatory requirements and to align with existing company policies
- Performing impact assessments for development and revised controlled procedures
- Conducting periodic SOP gap assessment and provides remediation based on findings
- Assisting with establishing and implementing monitoring plans for clinical studies
Your background should include:
- 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 planning and conducting complex regulatory inspections
- Expert knowledge of FDA, ICH principles and FDA Regulatory guidelines as it relates to clinical trial conduct
- Strong CAPA knowledge and experience
- Strong understanding of appropriate global medical device/IVD requirements, such as: ICH E6 (GCP), European Union (ISO13485:2016, ISO14971, IVDD/IVDR), US [21 CFR Part 812], etc.
- Preference for Quality Certification or credentials
- Demonstrated ability to initiate process improvement and take initiative
- Familiarity with the DIA Trial Master File Reference model and a demonstrated understanding of records management best practices
- 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%
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.
To apply for this position or to learn more, please click "Apply Online" below.
SOCRA Exp: 7/16/2022