Senior Supplier Quality Auditor
Bristol Myers Squibb
August 31, 2026
Remote friendly (Lawrence, NJ)
United States
Operations
Senior Supplier Quality Auditor
Job Responsibilities:
- Plan, schedule, and conduct onsite and remote audits of suppliers and external service providers per the approved supplier audit program.
- Evaluate supplier compliance with FDA/EMA/ICH requirements, internal SOPs, and quality agreements.
- Document audit observations; develop effective CAPAs with suppliers and internal stakeholders.
- Track CAPAs to closure and verify timely implementation and effectiveness.
- Maintain complete supplier audit records; communicate audit results and risk assessments.
- Support regulatory inspections/inspection readiness for supplier oversight and audit programs.
- Provide guidance/training on supplier audit processes and GxP compliance.
- Participate in continuous improvement for supplier quality oversight.
- Domestic travel to supplier sites required.
Education and Experience:
- Bachelor’s degree in Life Sciences, Chemistry, or related field (or equivalent experience).
- 7+ years in quality assurance, auditing, or supplier management in pharma/biotech/cGMP.
- Auditing experience in regulated biotech/pharma/GxP environment; at least 3 years in auditing or QA.
- Knowledge of global GxP (e.g., 21 CFR Parts 11/210/211, EudraLex Volume 4, ICH).
- Experience auditing across GMP, GLP, and/or GCP.
Skills/Qualifications:
- Identify systemic quality and compliance risks.
- Strong analytical, communication, and technical/report-writing skills.
- Ability to work independently, manage multiple priorities, and use AI tools to improve productivity/quality.
Compensation:
- Remote (United States): $96,148–$116,508.
Benefits:
- Eligible for comprehensive benefits, including medical/dental/vision, life/disability, retirement/financial protection; U.S. exempt employees receive Flexible Time Off and 11 paid holidays (subject to plan terms).
Job Responsibilities:
- Plan, schedule, and conduct onsite and remote audits of suppliers and external service providers per the approved supplier audit program.
- Evaluate supplier compliance with FDA/EMA/ICH requirements, internal SOPs, and quality agreements.
- Document audit observations; develop effective CAPAs with suppliers and internal stakeholders.
- Track CAPAs to closure and verify timely implementation and effectiveness.
- Maintain complete supplier audit records; communicate audit results and risk assessments.
- Support regulatory inspections/inspection readiness for supplier oversight and audit programs.
- Provide guidance/training on supplier audit processes and GxP compliance.
- Participate in continuous improvement for supplier quality oversight.
- Domestic travel to supplier sites required.
Education and Experience:
- Bachelor’s degree in Life Sciences, Chemistry, or related field (or equivalent experience).
- 7+ years in quality assurance, auditing, or supplier management in pharma/biotech/cGMP.
- Auditing experience in regulated biotech/pharma/GxP environment; at least 3 years in auditing or QA.
- Knowledge of global GxP (e.g., 21 CFR Parts 11/210/211, EudraLex Volume 4, ICH).
- Experience auditing across GMP, GLP, and/or GCP.
Skills/Qualifications:
- Identify systemic quality and compliance risks.
- Strong analytical, communication, and technical/report-writing skills.
- Ability to work independently, manage multiple priorities, and use AI tools to improve productivity/quality.
Compensation:
- Remote (United States): $96,148–$116,508.
Benefits:
- Eligible for comprehensive benefits, including medical/dental/vision, life/disability, retirement/financial protection; U.S. exempt employees receive Flexible Time Off and 11 paid holidays (subject to plan terms).