Senior Supplier Quality Auditor

🕒 July 31

🇺🇸 United States – Remote

💵 $96.1k - $116.5k / year

⏰ Full Time

🟠 Senior

🔎 Auditor

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 16%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1887

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

📋 Description

• Lead planning, execution, and reporting of supplier and service provider audits • Plan, schedule, and conduct onsite and remote audits of suppliers and external service providers • Evaluate supplier compliance with FDA, EMA, and ICH requirements, internal SOPs, and quality agreements • Document supplier audit observations and collaborate on CAPAs • Track supplier CAPAs to closure and verify timely implementation and effectiveness • Maintain supplier audit records and communicate audit results and risk assessments • Support regulatory inspections and inspection readiness activities related to supplier oversight and audit programs • Provide guidance and training on supplier audit processes and GxP compliance expectations • Participate in continuous improvement initiatives related to supplier quality oversight and audit processes • Travel domestically to supplier sites

🎯 Requirements

• 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 • At least 3 years in auditing or quality assurance • Auditing experience within regulated biotech/pharma industry or equivalent in a GxP-regulated environment • Strong knowledge of global GxP regulations and standards, including 21 CFR Parts 11, 210, and 211; EudraLex Volume 4; and ICH Guidelines • Experience conducting audits across GMP, GLP, and/or GCP domains • 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 • Strong communication and stakeholder management skills • Sound quality judgment

🏖️ Benefits

• Additional discretionary incentive cash • Stock opportunities • Wellbeing support • Retirement and financial protection benefits • Medical, dental, vision, life, and disability insurance offerings • Flexible Time Off (FTO) for U.S.-based exempt employees • 11 paid company holidays each year • 160 hours of paid vacation annually for new hires for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico • 3 optional holidays for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico • Paid sick leave, depending on eligibility • Up to two paid volunteer days per year • Summer hours flexibility • Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs • Annual Global Shutdown between Christmas Day and New Year's Day