Senior Supplier Quality Auditor

About this role

Life at BMS At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio 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. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio:  https://careers.bms.com/rayzebio/

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. #LI-ONSITE

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Remote - United States - US: $96,148 - $116,508
 The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

RayzeBio and Bristol Myers Squibb RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities BMS and RayzeBio are dedicated to

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