Senior Quality Auditor

Bristol Myers Squibb • Indianapolis, IN

2d • Onsite

About The Position

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 Senio r Quality A uditor 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.

Requirements

• 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.
• 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.

Nice To Haves

• Auditor certification (e.g., ASQ CQA, RQAP-GCP) is strongly preferred.
• Familiarity with electronic quality systems and audit management tools is preferred.

Responsibilities

• 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.

Benefits

• 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.
• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
• Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
• Other perks like tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees