Auditor, Vendor Quality
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Job Detail
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Job Description
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
This position supports the external vendor audit program and acts as a Subject Matter Expert (SME) for Vendor Qualification and Approval at the Indianapolis site. The candidate will also oversee vendor lifecycle management, with experience in conducting internal and vendor audits across early to late phases and commercial CGMP pharmaceutical manufacturing and testing. A working knowledge of FDA and EU regulations is required. Experience with Electronic Quality Management Systems (EQMS) such as SAP, TrackWise, MasterControl, and Veeva is beneficial. Knowledge in microbiology and radiopharmaceuticals is a plus.
Job Responsibilities:
- Author and maintain external audit schedule
- Schedule and coordinate external vendor audits
- Review, communicate and track audit findings
- Create, review, approve, and track corrective actions related to external audits.
- Support the review, discussion and approval of Quality Agreements for external vendors
- Participate in vendor reviews, provide input for the topics that relate to vendor performance and audits outcome.
- Support site activities that relate to the vendor change notification program and vendor complaint management program.
- Help establish and maintain the Vendor Management program
- 50% of travel or as required
- Direct communication to Vendor, schedule and conduct on site, virtual or paper audit/assessment
- Report writing and Vendor performance metrics
- Ensure suppliers are qualified and conduct audits at defined frequencies as part of the supplier monitoring process.
- Supporting an early phase to commercial facility
Education and Experience:
- 4-year science degree, advanced degree a plus
- 5 years of GMP Pharmaceutical manufacturing or equivalent, late phase and commercial preferred
- ASQ Auditing certificate or equivalent a plus
Skills and Qualifications:
- FDA CFR and EU Annex regulations
- Analytical problem solving
- Pharmaceutical manufacturing with parenteral experience
- Writing procedures, reports, metrics and dashboard
The starting compensation for this job is a range from $79,841-108,020, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is 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. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment 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 if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.