Senior QA Manager, GCP GXP Auditor

Job description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: Lead internal audit of GCP systems and relative departments, following up through CAPA implementation. Perform GxP internal audits to applicable regulations including completing audit reports and follow-up on corrective actions. Perform audits of TMFs for various programs. Assure oversight of CROs. Understand the clinical development process and demonstrate capability to manage the internal clinical audit program. Creat...