Senior Quality Auditor
Senior Quality Auditor
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Job Description
Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. 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: 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.
The Senior Quality Auditor is responsible for planning executing and reporting on internal and external audits to ensure compliance with applicable GxP regulations (GMP GLP GCP) internal procedures and industry standards. This role supports the continuous improvement of RayzeBios Quality Management System and ensures readiness for regulatory inspections and commercial operations.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
Plan schedule and conduct audits of internal departments suppliers and service providers in accordance with the audit program.
Evaluate compliance with applicable regulatory requirements (e.g. FDA EMA ICH) internal SOPs and quality agreements.
Document audit findings and collaborate with stakeholders to develop effective CAPAs.
Track and verify the implementation and effectiveness of CAPAs.
Maintain audit records and ensure timely communication of audit outcomes.
Support regulatory inspections and inspection readiness activities.
Provide guidance and training on audit processes and GxP compliance expectations.
Participate in continuous improvement initiatives related to quality systems and audit processes.
Travel to supplier sites and other company locations may be required.
Education and Experience
Bachelors degree in Life Sciences Chemistry or related field is required.
Minimum of 7-10 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 a GxP-regulated environment with at least 3 years in auditing or quality assurance.
Experience conducting audits across GMP GLP and/or GCP domains.
Skills and Qualifications
Auditor certification (e.g. ASQ CQA RQAP-GCP) is strongly preferred.
Familiarity with electronic quality systems and audit management tools is preferred.
Experience with international audits and regulatory inspections is required.
Strong knowledge of global GxP regulations and standards (e.g. 21 CFR Parts; EudraLex Volume 4; ICH Guidelines) is required.
Excellent analytical communication and report-writing skills are required.
Must be capable of working independently and handling several tasks simultaneously.
WorkEnvironment
The noise level in theworkenvironment is usually moderate.
#RayzeBio GPS2025 #LI-Onsite
If you come across a role that intrigues you but doesnt 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.
Compensation Overview:
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 employees 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 offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical pharmacy dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability life insurance supplemental health insurance business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours flexibility. Parental caregiver bereavement and military leave. Family care services such as adoption and surrogacy reimbursement fertility/infertility benefits support for traveling mothers and child elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
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 a supportive culture promoting global participation 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 an 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 . Visit 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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Senior IC
Employment Type
Full-Time
