Bristol Myers Squibb
Senior Quality Auditor – RayzeBio, a Bristol Myers Squibb Company
Location: Indianapolis, IN
Compensation Overview: $96,148 - $116,508 per year. Additional incentive cash and stock opportunities, if eligible, may be available. Base pay is determined by experience, skills and other job-related factors.
Job Responsibilities
Plan, schedule, and conduct audits of internal departments, suppliers, and service providers in accordance with the audit program.
Evaluate compliance with 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 related field.
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 in auditing or quality assurance within a GxP-regulated environment.
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.
Experience with international audits and regulatory inspections.
Strong knowledge of global GxP regulations (21 CFR, EudraLex, ICH Guidelines).
Excellent analytical, communication, and report‑writing skills.
Ability to work independently and handle multiple tasks simultaneously.
Work Environment The noise level in the work environment is usually moderate.
Benefits Medical, pharmacy, dental, and vision care; wellbeing support programs; 401(k) plan; paid vacation and holidays; parental, caregiver, and military leave; tuition reimbursement options; and other employee assistance programs. For full details, visit the BMS careers site.
Equal Employment Opportunity BMS is dedicated to a workforce that is diverse, inclusive, and equitable. All job applicants and employees are judged strictly on merit, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, veteran status, or genetics. The company provides reasonable accommodation and adjustments during the recruitment process and in workplace accommodations. For more information, visit careers.bms.com/eeo.
All data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Additional Information Applicants can request a reasonable accommodation in the recruitment process by contacting adastaffingsupport@bms.com.
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Compensation Overview: $96,148 - $116,508 per year. Additional incentive cash and stock opportunities, if eligible, may be available. Base pay is determined by experience, skills and other job-related factors.
Job Responsibilities
Plan, schedule, and conduct audits of internal departments, suppliers, and service providers in accordance with the audit program.
Evaluate compliance with 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 related field.
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 in auditing or quality assurance within a GxP-regulated environment.
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.
Experience with international audits and regulatory inspections.
Strong knowledge of global GxP regulations (21 CFR, EudraLex, ICH Guidelines).
Excellent analytical, communication, and report‑writing skills.
Ability to work independently and handle multiple tasks simultaneously.
Work Environment The noise level in the work environment is usually moderate.
Benefits Medical, pharmacy, dental, and vision care; wellbeing support programs; 401(k) plan; paid vacation and holidays; parental, caregiver, and military leave; tuition reimbursement options; and other employee assistance programs. For full details, visit the BMS careers site.
Equal Employment Opportunity BMS is dedicated to a workforce that is diverse, inclusive, and equitable. All job applicants and employees are judged strictly on merit, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, veteran status, or genetics. The company provides reasonable accommodation and adjustments during the recruitment process and in workplace accommodations. For more information, visit careers.bms.com/eeo.
All data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Additional Information Applicants can request a reasonable accommodation in the recruitment process by contacting adastaffingsupport@bms.com.
#J-18808-Ljbffr