Sr. Specialist, QA Operations

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do.

About the role

The Senior Specialist, QA Operations will help support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN. This role provides oversight over shop floor activities in accordance with regulatory standards and RayzeBio procedures, and is responsible for material and batch disposition activities. The position ensures 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.

Responsibilities

• 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.
• Use AI tools to enhance individual productivity and quality of work.
• Make sound decisions by exercising judgment within generally defined practices and policies and apply appropriate notification to management as needed.
• Participate as requested in the response team for audits and inspections by health authorities.

Requirements

• BS/MS degree in a 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

• 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.

Pay

The starting compensation range for this full-time role is $82,236 - $99,650. 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.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support Programs: 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:
  • 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 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 Year's 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.