Senior Quality Auditor Indianapolis, IN

Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers . If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.

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.

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.

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.

Additional Qualifications / Responsibilities

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.

Work Environment

The noise level in the work environment is usually moderate.

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 :

Indianapolis - RayzeBio - IN : $96148 - $116508

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.

Required Experience :

Senior IC

Key Skills

Quality Assurance,Quality Inspection,Calipers,ISO 9001,Quality Audits,Process Mapping,Fair Housing Regulations,Quality Control,Underwriting,cGMP,As9100,Manufacturing

Employment Type : Full Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 96148 - 116508