Lead, author, review, and approve quality investigations related to deviations/nonconformances, complaints, temperature excursions, audit findings, and other quality events
Perform structured root cause analysis using appropriate tools such as 5 Whys, Fishbone, Fault Tree Analysis, risk assessment, and process mapping
Leverage existing launch training materials to design, implement, and continuously improve a comprehensive onboarding curriculum for new Oncology Sales Team hires
Partner cross-functionally with subject matter experts to develop and execute learning programs and workshops that support field and business needs
Develop/manage study audit plans ensuring compliance oversight for assigned studies by using a risk-based approach
Lead/manage Good Clinical Practice (GCP) audits, including clinical investigator site, Trial Master File (TMF), and applicable study documents, including Clinical Study Reports (CSRs)
