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. 10-15% of travel may be required.
Job ResponsibilitiesEssential 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 EnvironmentThe noise level in the work environment is usually moderate.
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Compensation Overview:Indianapolis - RayzeBio - IN: $96,148 - $116,508
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- 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 include:Paid Time Off
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
RayzeBio and Bristol Myers SquibbRayzeBio 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.
