Senior Supplier Quality Auditor
Listed on 2026-07-24
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers
About Rayze Bio
At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly‑owned subsidiary of Bristol Myers Squibb, Rayze Bio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer.
Role SummaryThe 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 and supports supplier qualification and monitoring programs.
Job 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 regulatory requirements (e.g., FDA, EMA, ICH), internal SOPs, and executed quality agreements.
- Document 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 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 audit processes and GxP compliance expectations.
- Participate in continuous improvement initiatives related to supplier quality oversight and audit processes.
- Domestic travel to supplier sites is required.
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 a 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; Eudra Lex Volume 4; ICH Guidelines).
Experience conducting audits across GMP, GLP, and/or GCP domains.
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.
- Advanced technical writing skills for audit reports and regulatory documentation.
- Sound quality judgment and stakeholder management skills.
- Experience using AI tools to enhance productivity and quality of work.
The noise level in the work environment is usually moderate. Domestic travel to supplier sites is required.
Compensation OverviewIndianapolis - Rayze Bio - IN: $96,148 - $116,508 (full‑time employee basis). Additional incentive cash and stock opportunities may be available.
Benefits- Health Coverage:
Medical, pharmacy, dental, and vision care. - Wellbeing Support:
Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). - Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Work‑life benefits:
Paid Time Off, flexible time off, national holidays, optional holidays, unlimited paid sick time, volunteer days, summer hours flexibility, leaves of absence, and an annual Global Shutdown.
Visit to access our complete Equal Employment Opportunity statement.
Support for People with DisabilitiesBMS and Rayze Bio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
Candidate RightsBMS and Rayze Bio will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County, visit for additional information.
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ContactJob Title:
Senior Supplier Quality Auditor
Requisition Number: R1600772
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