Senior Specialist QA Operations

Working with Us

Challenging. Meaningful. Life‑changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day in every department—from optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients and the careers of those who do it.

You’ll have the chance to grow and thrive through opportunities that are uncommon in scale and scope, alongside high‑achieving teams. Take your career farther than you thought possible.

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Rayze Bio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company focuses on improving the survival of people with cancer by harnessing the power of targeted radioisotopes. Rayze Bio is developing innovative drugs against targets of solid tumors and aims tonice the global leader in radiopharmaceuticals.

The Senior Specialist, QA Operations will help support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN. The Senior QA Operations specialist will provide oversight over shop‑floor activities in accordance with regulatory standards and Rayze Bio procedures, and will also be responsible for material and batch disposition activities. This position will utilize QA knowledge to ensure compliance in operations, supporting clinical development and GMP commercial operations in accordance with Rayze Bio policies, standards, procedures and global current Good Manufacturing Practice (cGMP).

The Senior Specialist provides quality support and oversight for operations and disposition activities at the Indianapolis facility, including review and approval of deviations, CAPAs, change controls, documents, batch records, and material and lot disposition. The Senior Specialist may also interact with the Qualified Person (QP) as needed to facilitate release of EU doses.

• Build and maintain cross‑functional relationships to improve processes and resolve issues.
• Provide quality oversight on manufacturing and validation activities.
• Perform real‑time review of manufacturing records.
• Perform periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance with procedures.
• Provide guidance on the handling of quality and shop‑floor activities.
• Support quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.
• Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation.
• Identify and report discrepancies from required work practices or procedures to management.
• Make sound decisions by exercising judgment within generally defined practices and policies and applying appropriate notification to management as appropriate.
• Participate as requested in the response team for audits and inspections by health authorities.

• BS/MS degree in a science‑related field (biology, biochemistry, chemistry, engineering, or related areas) is preferred.
• Minimum of 5 years’ experience in quality assurance and/or compliance roles in the pharmaceutical industry or a related industry.
• Experience working in a GMP aseptic manufacturing environment preferred.
• Experience working with FDA or other regulatory authorities is preferred.

• Expertise in GMP, quality, material and product disposition.
• Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with quality risk management principles.
• Detail‑oriented with demonstrated application of problem solving and decision‑making abilities under…