Bristol Myers Squibb
Senior Quality Auditor – RayzeBio, Indianapolis, IN
RayzeBio, a Bristol Myers Squibb company, is leading the development of targeted radioisotopes for solid tumor therapy. The Senior Quality Auditor is responsible for planning, executing, and reporting on internal and external audits to ensure compliance with GxP regulations (GMP, GLP, GCP), internal procedures, and industry standards. This role supports continuous improvement of RayzeBio’s Quality Management System and prepares the company for regulatory inspections and commercial operations.
Job 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 (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 as required.
Education and Experience
Bachelor’s degree in Life Sciences, Chemistry, or a related field – required.
Minimum of 7–10 years of experience in quality assurance, auditing, or supplier management within the pharmaceutical, biotechnology, or cGMP industry.
At least 3 years of experience in auditing or quality assurance in a regulated biotech/pharma environment.
Experience conducting audits across GMP, GLP, and/or GCP domains.
Skills and Qualifications
Auditor certification (e.g., ASQ CQA, RQAP‑GCP) strongly preferred.
Familiarity with electronic quality systems and audit management tools.
Experience with international audits and regulatory inspections required.
Strong knowledge of global GxP regulations and standards (21 CFR Parts 11, 210, 211; EudraLex Volume 4; ICH Guidelines) required.
Excellent analytical, communication, and report‑writing skills required.
Capability to work independently and handle multiple tasks simultaneously.
Work Environment The noise level in the work environment is usually moderate.
Compensation Overview Indianapolis – RayzeBio – IN: $96,148 – $116,508 (annual salary). Additional incentive cash and equity may be available based on eligibility. Final compensation is determined by demonstrated experience and qualifications.
Benefits Summary Medical, pharmacy, dental, and vision coverage; wellbeing programs; employee assistance; financial wellness resources; 401(k) with company match; disability, life, and supplemental insurance; paid holiday and optional holiday schedule; flexible vacation; parental, caregiver, and military leave; family care and educational reimbursement benefits.
Equal Employment Opportunity RayzeBio is an equal opportunity employer. We encourage applicants of all backgrounds, including individuals with disabilities. For more on accommodations and the complete Equal Employment Opportunity statement, visit https://careers.bms.com/eeo-accessibility.
Data Protection We do not request payments or sensitive personal data during the application process. All data processed in connection with this role are treated in accordance with applicable privacy policies and regulations. Learn more at https://careers.bms.com/fraud-protection.
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Job 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 (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 as required.
Education and Experience
Bachelor’s degree in Life Sciences, Chemistry, or a related field – required.
Minimum of 7–10 years of experience in quality assurance, auditing, or supplier management within the pharmaceutical, biotechnology, or cGMP industry.
At least 3 years of experience in auditing or quality assurance in a regulated biotech/pharma environment.
Experience conducting audits across GMP, GLP, and/or GCP domains.
Skills and Qualifications
Auditor certification (e.g., ASQ CQA, RQAP‑GCP) strongly preferred.
Familiarity with electronic quality systems and audit management tools.
Experience with international audits and regulatory inspections required.
Strong knowledge of global GxP regulations and standards (21 CFR Parts 11, 210, 211; EudraLex Volume 4; ICH Guidelines) required.
Excellent analytical, communication, and report‑writing skills required.
Capability to work independently and handle multiple tasks simultaneously.
Work Environment The noise level in the work environment is usually moderate.
Compensation Overview Indianapolis – RayzeBio – IN: $96,148 – $116,508 (annual salary). Additional incentive cash and equity may be available based on eligibility. Final compensation is determined by demonstrated experience and qualifications.
Benefits Summary Medical, pharmacy, dental, and vision coverage; wellbeing programs; employee assistance; financial wellness resources; 401(k) with company match; disability, life, and supplemental insurance; paid holiday and optional holiday schedule; flexible vacation; parental, caregiver, and military leave; family care and educational reimbursement benefits.
Equal Employment Opportunity RayzeBio is an equal opportunity employer. We encourage applicants of all backgrounds, including individuals with disabilities. For more on accommodations and the complete Equal Employment Opportunity statement, visit https://careers.bms.com/eeo-accessibility.
Data Protection We do not request payments or sensitive personal data during the application process. All data processed in connection with this role are treated in accordance with applicable privacy policies and regulations. Learn more at https://careers.bms.com/fraud-protection.
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