Senior Quality Auditor

Bristol Myers Squibb • Indianapolis, IN

2d • Onsite

About The Position

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. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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 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

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

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