Senior Specialist QA Operations

Senior Specialist QA Operations

Rayze Bio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. Rayze Bio develops innovative drugs against solid tumor targets, led by a successful entrepreneurial team and aim to be the global leader in radiopharmaceuticals.

The Senior Specialist, QA Operations will support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN. The role provides oversight over shop floor activities in accordance with regulatory standards and Rayze Bio procedures, and is responsible for material and batch disposition activities. Utilises quality assurance knowledge to ensure compliance in operations supporting clinical development and GMP commercial operations in accordance with Rayze Bio policies, standards, procedures and global 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. This person 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 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 problem‑solving and decision‑making abilities with moderate oversight from management.
• Team player who can work independently to achieve objectives in a fast‑paced environment.
• Excellent verbal and written communication skills.
• Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing.
• Knowledge of U.S., EU and rest‑of‑world cGMP regulations and guidance.
• Knowledge and proven experience in FDA, EMA, or other regulatory authority.
• Well‑practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required include close vision and distance vision. This position requires working in an environment with radioactive materials where protective clothing, gloves,…