Senior Supplier Quality Auditor
Bristol Myers Squibb
August 31, 2026
Remote friendly (Lawrence, NJ)
United States
Operations
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 regulatory requirements (e.g., FDA, EMA, ICH), internal SOPs, and executed quality agreements.
- Document audit observations and collaborate to develop effective CAPAs.
- Track CAPAs to closure and verify timely implementation and effectiveness.
- Maintain accurate supplier audit records; communicate audit results and risk assessments timely.
- Support regulatory inspections and inspection readiness related to supplier oversight.
- Provide guidance and training to suppliers and internal teams on audit processes and GxP compliance expectations.
- Participate in continuous improvement initiatives for supplier quality oversight and audit processes.
- Domestic travel to supplier sites is required.
Qualifications/Requirements
- Bachelor’s degree in Life Sciences, Chemistry, or related field, or equivalent experience.
- Minimum 7 years’ experience in quality assurance, auditing, or supplier management in pharmaceutical/biotech/cGMP.
- At least 3 years in auditing or quality assurance in a GxP-regulated environment (auditing experience in regulated biotech/pharma preferred).
- Strong knowledge of global GxP regulations/standards (e.g., 21 CFR Parts 11, 210, 211; EudraLex Volume 4; ICH Guidelines).
- Experience conducting audits across GMP, GLP, and/or GCP.
- Demonstrable ability to identify systemic quality and compliance risks.
Skills
- Proven ability to identify systemic quality/compliance risks.
- Excellent analytical, communication, and report-writing; strong technical writing for audit/regulatory documentation.
- Ability to work independently, manage multiple priorities, and use AI tools to improve productivity/quality.
- Sound quality judgment; strong stakeholder management.
Compensation (US)
- Remote, United States: $96,148–$116,508.
Benefits
- Eligible to participate in comprehensive benefits plans (medical, dental, vision, life, disability), FTO for US exempt employees, and vacation/holidays for eligible non-exempt employees; additional time-off depending on eligibility.
- Plan, schedule, and conduct onsite and remote audits of suppliers and external service providers per the approved supplier audit program.
- Evaluate supplier compliance with regulatory requirements (e.g., FDA, EMA, ICH), internal SOPs, and executed quality agreements.
- Document audit observations and collaborate to develop effective CAPAs.
- Track CAPAs to closure and verify timely implementation and effectiveness.
- Maintain accurate supplier audit records; communicate audit results and risk assessments timely.
- Support regulatory inspections and inspection readiness related to supplier oversight.
- Provide guidance and training to suppliers and internal teams on audit processes and GxP compliance expectations.
- Participate in continuous improvement initiatives for supplier quality oversight and audit processes.
- Domestic travel to supplier sites is required.
Qualifications/Requirements
- Bachelor’s degree in Life Sciences, Chemistry, or related field, or equivalent experience.
- Minimum 7 years’ experience in quality assurance, auditing, or supplier management in pharmaceutical/biotech/cGMP.
- At least 3 years in auditing or quality assurance in a GxP-regulated environment (auditing experience in regulated biotech/pharma preferred).
- Strong knowledge of global GxP regulations/standards (e.g., 21 CFR Parts 11, 210, 211; EudraLex Volume 4; ICH Guidelines).
- Experience conducting audits across GMP, GLP, and/or GCP.
- Demonstrable ability to identify systemic quality and compliance risks.
Skills
- Proven ability to identify systemic quality/compliance risks.
- Excellent analytical, communication, and report-writing; strong technical writing for audit/regulatory documentation.
- Ability to work independently, manage multiple priorities, and use AI tools to improve productivity/quality.
- Sound quality judgment; strong stakeholder management.
Compensation (US)
- Remote, United States: $96,148–$116,508.
Benefits
- Eligible to participate in comprehensive benefits plans (medical, dental, vision, life, disability), FTO for US exempt employees, and vacation/holidays for eligible non-exempt employees; additional time-off depending on eligibility.