Senior Supplier Quality Auditor
Bristol Myers Squibb · Remote
The Senior Supplier Quality Auditor is responsible for leading the planning, execution, and reporting of supplier and service provider audits to ensure compliance with applicable cGMP/GxP regulations, internal procedures, and quality agreements. This role provides independent quality oversight of critical suppliers, supports supplier qualification and monitoring programs.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
Plan, schedule, and conduct onsite and remote audits of suppliers and external service providers in accordance with the approved supplier audit program.
Evaluate supplier compliance with applicable regulatory requirements (e.g., FDA, EMA, ICH), internal SOPs, and executed quality agreements.
Document supplier audit observations and collaborate with suppliers and internal stakeholders to develop appropriate and effective CAPAs.
Track supplier CAPAs to closure and verify timely implementation and effectiveness.
Maintain complete and accurate supplier audit records and ensure timely communication of audit results and risk assessments.
Support regulatory inspections and inspection readiness activities related to supplier oversight and audit programs.
Provide guidance and training to suppliers and internal teams on supplier audit processes and GxP compliance expectations.
Participate in continuous improvement initiatives related to supplier quality oversight and supplier audit processes.
Domestic travel to supplier sites is required.
Education and Experience
Bachelor’s degree in Life Sciences, Chemistry, or a related field or equivalent experience.
Minimum of 7 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.
Strong knowledge of global GxP regulations and standards (e.g., 21 CFR Parts 11, 210, 211; EudraLex Volume 4; ICH Guidelines).
Experience conducting audits across GMP, GLP, and/or GCP domains.
Demonstrable ability to identify systemic quality and compliance risks
Skills and Qualifications
Proven ability to identify systemic quality and compliance risks
Excellent analytical, communication, and report-writing skills.
Ability to work independently and manage multiple priorities.
Ability to utilize AI tools to enhance individual productivity and quality of work
Strong technical writing skills for audit reports and regulatory documentation
Sound quality judgment and ability to work independently
Strong communication and stakeholder management skills
Uses AI tools to enhance individual productivity and quality of work
Work Environment
The noise level in the work environment is usually moderate.
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