Sr. Specialist, QA Operations

Role: Senior Specialist, QA Operations supporting radiopharmaceutical manufacturing at RayzeBio in Indianapolis, IN. Responsibilities: provide quality oversight of shop floor activities, review and approve deviations, CAPAs, change controls, batch records, and material dispositions; support compliance with GMP, FDA, EU, and global regulations; facilitate manufacturing and validation activities; assist in investigations and regulatory interactions, including interactions with Qualified Persons for EU product releases; leverage AI tools to enhance productivity. Requirements: BS/MS in biology, biochemistry, chemistry, engineering, or related field; minimum 5 years of QA/Compliance experience within pharma, preferably in GMP aseptic production; strong knowledge of GMP, product/material disposition, investigations, and regulatory standards. Preferred: experience with FDA, EMA, or global authorities; background in clinical or commercial radiopharmaceutical manufacturing; expertise in quality systems. High-Value: radiopharmaceuticals, GMP compliance, clinical and commercial operations, regulatory oversight, and experience supporting radioactive material environments. Work setup: onsite in Indianapolis with potential for occasional non-standard hours and weekend work.