Senior GCP Compliance Auditor

at AbbVie US LLC in North Chicago, Illinois, United States

Job Description

Senior GCP Compliance Auditor, AbbVie Inc., North Chicago, Illinois. Responsible for ensuring high quality clinical trials are performed in compliance with worldwide regulatory expectations. Demonstrate good scientific rationale and interpretation of data integrity through regulatory submissions. Responsible for preparing, conducting, and reporting audit activities of clinical trials activities utilizing software such as TrackWise, Salesforce, IMPACT, Veeva Vault, Spotfire, Medidata, InForm, YPrime, Endpoint, Premier, Calyx, CRF Health, etc. Responsible for leading investigator site audits to ensure compliance with global regulatory requirements. Lead internal audits to assess the systems processed and procedures in place to support the clinical trial conduct and their overall compliance with ICH GCP guidelines, applicable regulations, and the organization’s Quality System. Appropriate protection of all human subjects participating in organizational Clinical Trials. Assist with Clinical QA program management activities in support of studies and projects to ensure compliance with regulations, guidelines, policies, procedures and sponsor requirements. Deliver consistent, high-quality documents and clinical program activities for Research and Development (R&D). Ensure that R&D remains in compliance with worldwide regulatory expectations and requirements. Lead and develop strategy for global Quality Assurance in alignment with R&D strategies. Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures. Plan, organize and lead multiple GCP vendor compliance audits on a global scale. Initiate, manage, and participate in quality improvement projects. Prepare and present project progress reports to update management and keep the team(s) informed. Must possess a Bachelor’s degree or foreign academic equivalent in Physical Science, Life Science, Biochemistry, Cellular and Molecular Biology, Engineering or a highly related field of study with at least two (2) years of related experience in the following: (i) demonstrating good scientific rationale and interpretation of data integrity through regulatory submissions; (ii) preparing, conducting, and reporting audit activities of clinical trials activities utilizing software such as such as TrackWise, Salesforce, IMPACT, Veeva Vault, Spotfire, Medidata, InForm, YPrime, Endpoint, Premier, Calyx, CRF Health, etc; (iii) assisting with Clinical QA program management activities in support of studies and projects to ensure compliance with regulations, guidelines, policies, procedures and sponsor requirements; and (iv) initiating, managing, and participating in quality improvement projects. Apply online at https://careers.abbvie.com/en & reference REF22825A.