Sr. Specialist, QA Operations

At RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, we blend 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. 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 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, including review and approval of deviations, CAPAs, change controls, documents, batch records, and material and lot disposition. This role may also interact with the Qualified Person (QP) 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.
• Conduct 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 the Quality disposition process by ensuring all required documents are accurately completed and compiled against approved procedures and specifications, including 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 notify management as appropriate.
• Participate in the response team for audits and inspections by health authorities as requested.

Requirements

• BS/MS degree in a science-related field (e.g., 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 problem-solving and decision-making abilities with moderate oversight from management.
• Ability to work independently and as a team player in a fast-paced environment.
• Excellent verbal and written communication skills.
• Strong background and demonstrated effectiveness in quality assurance operations and compliance of clinical/commercial manufacturing.
• Knowledge of US, EU, and rest-of-world cGMP regulations and guidance.
• Knowledge and proven experience with FDA, EMA, or other regulatory authorities.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.

Physical Demands

• Regularly required to sit, reach with hands and arms, and talk or hear.
• Occasionally required to lift and/or move up to 30 pounds.
• Specific vision abilities required include close vision and distance vision.
• Work in an environment with radioactive materials where protective clothing, gloves, and safety glasses are required.

Work Environment

• Moderate noise level in the work environment.
• May require work outside of normal working hours or on weekends.

Pay

Starting compensation range for this full-time role in Indianapolis is $82,236 - $99,650. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account required skills, job location, 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 such as 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 for US Exempt Employees: Flexible time off (unlimited, with manager approval) and 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or RayzeBio).
  • Paid Time Off for 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.
  • 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 (eligibility applies).