Sr. Manager, Quality Assurance Quality Control

Sr. Manager, Quality Assurance for Quality Control

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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.

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

The Senior Manager, QA for QC is responsible for quality oversight of the Quality Control (QC) Analytical and Quality Control Microbiology laboratory operations at the Rayze Bio facility in Indianapolis in accordance with Rayze Bio policies, standards, procedures and global current Good Manufacturing Practice (cGMP). The Senior Manager provides Quality support and oversight for QC laboratory operations such as sample management, testing, and data review, method development, validation, and transfer, equipment validation, and associated projects.

The Senior Manager supports thorough review and approval of QC investigations, change control records, Standard Operating Procedures, Method validation and transfer documents, and technical protocols, and assists in preparing for regulatory audits.

• Quality Assurance support and oversight of QC (Analytical and Microbiological) laboratory operations including laboratory investigations, deviations, corrective or preventative actions, method development, validation, and transfer activities, equipment validation work and associated projects.
• Quality Assurance support of QC associated with the manufacturing process including QC activity related to in process and release product testing, raw material testing, and environmental monitoring activities.
• Assesses QC driven change controls and supports completion of any associated change actions.
• Participates in ongoing laboratory operations/continuous improvement and risk management projects.
• Participates in risk assessments related to QC laboratory operations.
• Identifies and reports discrepancies from required work practices or procedures to management.
• Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
• Participates as requested in the response team for audits and inspections by health authorities.
• Conducts regular walkthroughs of QC laboratories.
• Performs review and approval of Quality, Laboratory, and Analytical Standard Operating Procedures (SOPs) and documents.
• Provides oversight to identify and implement changes that lead to realization of long‑term department and company goals.

• Bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry) is required.
• Minimum 10+ years relevant work experience (analytical development, Quality Control, and/or Quality Assurance), preferably in a regulated environment is required. Quality Assurance experience would be considered beneficial. An equivalent combination of education and experience may substitute.

• Knowledge of analytical method lifecycle including development, validation, and transfer.
• Practical understanding of common QC procedures, techniques, and laboratory equipment/instrumentation and the application and interpretation of most‑relevant GMP concepts and compendia requirements (e.g. US FDA, CFR, USP, EP, JP).
• Knowledge of Microbiological…