Bristol Myers Squibb · 2 hours ago
Senior Quality Auditor
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
$96K/yr - $117K/yr
7+ years expBristol Myers Squibb is a dynamic biotechnology company focused on improving survival rates for cancer patients through innovative drug development. The Senior Quality Auditor will be responsible for planning, executing, and reporting on audits to ensure compliance with GxP regulations and support the continuous improvement of the Quality Management System.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
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
Preferred
Auditor certification (e.g., ASQ CQA, RQAP-GCP) is strongly preferred
Familiarity with electronic quality systems and audit management tools is preferred
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.
Paid Time Off
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2025-12-30
BioWorld Financial Watch
2025-12-29
2025-12-25
Company data provided by crunchbase