Director, RayzeBio Quality Systems and Compliance

Bristol Myers Squibb • Indianapolis, IN

1d • Onsite

About The Position

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. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/ Summary The Director, RayzeBio Quality Systems and Compliance is responsible for providing leadership and expertise in creating, implementing, and communicating the execution and effectiveness of the Quality Management System (QMS) at RayzeBio. The QMS supports operations spanning Research and Development, non-Clinical, Clinical, Medical, CMC, Commercial, Regulatory, and IT. This role influences leadership on the strategic direction and tactical implementation of the quality systems for radiopharmaceutical operations (clinical, non-clinical, manufacturing, logistics, etc.) and establishes QMS specific quality objectives, priorities, and roadmap. He/she will lead and participate in critical projects supporting continuous quality improvement and provides both strategic and technical leadership to RayzeBio. The role will have people manager responsibilities, including managing people manager(s).

Requirements

• Bachelor’s degree in science, engineering, or pharmaceutical‑related discipline, or equivalent experience.
• 10+ years of pharmaceutical quality leadership experience with demonstrated cross‑functional collaboration.
• Previous experience in implementing and developing quality systems
• Previous experience in directly dealing with GMP health authority inspections
• Prior regulatory inspection readiness and inspection execution experience
• Strong knowledge of cGMP regulations and application to manufacturing operations.
• Extensive experience with Quality Management Systems, site compliance, and global regulatory requirements (e.g., FDA, ICH, USP, EP, JP).
• Demonstrated ability to build effective relationships and communicate across all organizational levels.
• Ability to successfully solve challenging issues, critical thinking, and detail oriented
• Strong interpersonal, verbal, and written communication skills
• Demonstrable record of strong leadership, negotiation skill, and teamwork in a cross-functional industry environment.
• Excellent written and verbal communication skills.
• Well-practiced in exercising sound judgment in decision-making, including risk-balanced approach.
• Demonstrated prioritization and organization skills.

Responsibilities

• Ensure that Quality Manual is available and up-to-date, all the time.
• Coordinate creation and execution of the annual Corporate Quality Plan.
• Facilitates RayzeBio enterprise quality council meetings
• Participate in defining short‑ and long‑term strategic direction for Quality Systems, including electronic systems, at RayzeBio with a vision towards “QA release by exception”.
• Ensure creation and implementation of Quality systems such as investigations, deviations, CAPA, change control, risk management, audits and inspections, training, supplier quality, document control, and management review and including electronic systems.
• Lead implementation of GxP electronic systems at RayzeBio (e.g., quality events, document management, electronic batch record, LIMS, ERP, Order to delivery patient experience system)
• Ensure systems are in place for release or rejection of raw materials, intermediates, packaging components, and consumables.
• Ensure supplier qualification program is created, maintained, and effective.
• Actively contribute in creating and implementing quality metrics and Annual Product Reviews.
• Ensure site inspection readiness; host audits and inspections and ensure timely closure of regulatory commitments.
• Assure adequacy and effectiveness of GxP quality systems.
• Ensure compliance with GxP regulations, corporate quality standards, and regulatory requirements through review/approval of GxP documentation, Data Integrity initiatives, and self-inspections.
• Maintain site compliance through gap assessments against corporate and regulatory standards.
• Partner with QA leadership to ensure adequate quality oversight of GxP activities.
• Support development and execution of the site operational readiness plan.
• Plan and execute internal audit and site self‑assessment programs.
• Ensure data integrity by design across electronic systems
• Ensure that the Indianapolis Site Master File is available and up-to-date all the time.

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 include: 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 for employees 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 Years 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees