QA Operations Leader — Radiopharma GMP & Compliance

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

Benefits offered by this job

Benefits package

Health insurance

PTO

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Senior Specialist, QA Operations in Indianapolis to oversee quality activities on the shop floor for radiopharmaceutical operations. The role ensures compliance with cGMP and company procedures while supporting material and batch disposition.

Responsibilities include reviewing investigations, CAPAs, deviations, and change controls, and collaborating with QA, Manufacturing, and QA/QC teams to maintain high quality standards for

Qualifications

• BS/MS degree in a science-related field preferred, including: Biology Biochemistry Chemistry Engineering
• Minimum of 5 years of experience in Quality Assurance and/or Compliance roles within the pharmaceutical industry
• Experience working in a GMP aseptic manufacturing environment preferred

Responsibilities

• Provide Quality oversight of shop floor activities and manufacturing/validation processes
• Review and approve Deviations, CAPAs, Change Controls, and batch records
• Dispositions of materials and lots with proper documentation
• Interact with regulatory authorities as needed for audits/inspections
• Use QA expertise to ensure compliance with cGMP in clinical and commercial operations
• Support investigations and QA approvals of GMP documentation

Skills

QA Operations

GMP

Regulatory knowledge

Investigations

Documentation

Cross-functional

Education

BS/MS in science

Tools

CAPA systems

Job description

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Senior Specialist, QA Operations in Indianapolis to oversee quality activities on the shop floor for radiopharmaceutical operations. The role ensures compliance with cGMP and company procedures while supporting material and batch disposition.

Responsibilities include reviewing investigations, CAPAs, deviations, and change controls, and collaborating with QA, Manufacturing, and QA/QC teams to maintain high quality standards for