Senior Specialist, QA Operations

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. Take your career farther than you thought possible.

Summary

The Senior Specialist, QA Operations will help support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN. The Senior QA Operations specialist will be providing oversight over shop floor activities in accordance with regulatory standards and RayzeBio procedures. The Senior QA Operations specialist will also be responsible for material and batch disposition activities. This position will utilize quality assurance knowledge in ensuring compliance in operations to support clinical development and GMP commercial operations in accordance with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice (cGMP).

The Senior Specialist provides Quality support and oversight for operations and disposition activities at the Indianapolis facility, including review and approval of Deviations, CAPAs, Change Controls, documents, Batch Records, and Material and Lot Disposition. This person may also interact with the Qualified Person (QP) as needed to facilitate release of EU doses.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

Build and maintain cross functional relationships to improve processes and resolve issues.

Provide quality oversight on manufacturing and validation activities.

Perform real time review of manufacturing records.

Perform periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance with procedures.

Provide guidance on the handling of quality and shop floor activities.

Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.

Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation.

Identify and report discrepancies from required work practices or procedures to management.

Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.

Participate as requested in the response team for audits and inspections by health authorities.

Education and Experience

BS / MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred

Minimum of 5 years’ experience in quality assurance and / or compliance roles in the pharmaceutical industry.

Experience working in a GMP aseptic manufacturing environment preferred.

Experience working with FDA or other regulatory authorities is preferred.

Skills and Qualifications

Expertise in GMP, Quality, material and product disposition

Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles

Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management

Team player who can work independently to achieve objectives in a fast-paced environment

Excellent verbal and written communication skills.

Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical / commercial manufacturing is desired.

Knowledge of US, EU and rest-of-world cGMP regulations and guidance.

Knowledge and proven experience in FDA, EMA, or other regulatory authority.

Well-practiced in exercising sound judgment in decision-making.

Demonstrated prioritization and organization skills.

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and / or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision.

This is a position that requires working in an environment with radioactive materials where protective clothing, gloves, and safety glasses are required.

Work Environment

The noise level in the work environment is usually moderate. This position may require work outside of normal working hours or on weekends.

#RayzeBio, GPS_2025, #LI-Onsite

Compensation Overview :

Indianapolis - RayzeBio - IN : $82,236 - $99,650

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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.