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Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

RayzeBio, 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. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

The Senior Quality Auditor is responsible for planning, executing, and reporting on internal and external audits to ensure compliance with applicable GxP regulations (GMP, GLP, GCP), internal procedures, and industry standards. This role supports the continuous improvement of RayzeBio’s Quality Management System and ensures readiness for regulatory inspections and commercial operations.  

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

• Plan, schedule, and conduct audits of internal departments, suppliers, and service providers in accordance with the audit program.

• Evaluate compliance with applicable regulatory requirements (e.g., FDA, EMA, ICH), internal SOPs, and quality agreements.

• Document audit findings and collaborate with stakeholders to develop effective CAPAs.

• Track and verify the implementation and effectiveness of CAPAs.

• Maintain audit records and ensure timely communication of audit outcomes.

• Support regulatory inspections and inspection readiness activities.

• Provide guidance and training on audit processes and GxP compliance expectations.

• Participate in continuous improvement initiatives related to quality systems and audit processes.

• Travel to supplier sites and other company locations may be required.

Education and Experience

• Bachelor’s degree in Life Sciences, Chemistry, or related field is required.

• Minimum of 7-10 years of experience in quality assurance, auditing, or supplier management within the pharmaceutical, biotechnology, or cGMP industry.

• Auditing experience within regulated biotech/pharma industry or equivalent.in a GxP-regulated environment, with at least 3 years in auditing or quality assurance.

• Experience conducting audits across GMP, GLP, and/or GCP domains.

Skills and Qualifications

• Auditor certification (e.g., ASQ CQA, RQAP-GCP) is strongly preferred.

• Familiarity with electronic quality systems and audit management tools is preferred.

• Experience with international audits and regulatory inspections is required.

• Strong knowledge of global GxP regulations and standards (e.g., 21 CFR Parts 11, 210, 211; EudraLex Volume 4; ICH Guidelines) is required.

• Excellent analytical, communication, and report-writing skills are required.

• Must be capable of working independently and handling several tasks simultaneously.

Work Environment

The noise level in the work environment is usually moderate.

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Indianapolis - RayzeBio - IN: $96,148 - $116,508

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