Senior QA Operations Lead, Radiopharma

Bristol Myers Squibb; Indianapolis (IN); On-site; USD 82,000 - 100,000; Full time

Benefits offered by this job

Flexible Time Off (FTO)

Paid holidays and time-off

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Senior Specialist, QA Operations in Indianapolis to provide quality oversight in a radiopharmaceutical facility. The role ensures compliance and supports material and batch disposition, with collaboration across QA and manufacturing teams.

You will review deviations, CAPAs, change controls, and documents, and may interact with the Qualified Person (QP) to facilitate EU dose releases.

Qualifications

• BS/MS degree in a science-related field.
• Minimum 5 years QA/Compliance in the pharmaceutical industry.
• GMP aseptic manufacturing experience preferred.
• FDA/regulatory authorities experience preferred.

Responsibilities

• Build cross-functional relationships to improve processes and resolve issues.
• Provide QA oversight on manufacturing and validation activities.
• Review manufacturing records in real time.
• Ensure continued compliance with procedures in walkthroughs of GMP areas.
• Support QA disposition and investigations, CAPAs, and changes.

Skills

GMP & quality

Investigations & QA reviews

Decision making

Communication

Regulatory knowledge

Prioritization & organization

Education

BS/MS in science

Job description

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Senior Specialist, QA Operations in Indianapolis to provide quality oversight in a radiopharmaceutical facility. The role ensures compliance and supports material and batch disposition, with collaboration across QA and manufacturing teams.

You will review deviations, CAPAs, change controls, and documents, and may interact with the Qualified Person (QP) to facilitate EU dose releases.