Senior Supplier Quality Auditor
Bristol Myers Squibb
•$96,148 - $116,508•Remote
About The Position
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.
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.
- 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
Nice To Haves
- 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
Responsibilities
- 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.
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays
- 160 hours of paid vacation annually
- 3 optional holidays
- paid sick leave
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
