Director, RayzeBio Quality Systems and Compliance

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 youll 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 impacton our science on our teams and most importantly on patients. Learn more about RayzeBio: 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).

Job 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 longterm 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 selfassessment 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.

Education and Experience

• Bachelors degree in science engineering or pharmaceuticalrelated discipline or equivalent experience.
• 10 years of pharmaceutical quality leadership experience with demonstrated crossfunctional 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.

Physical Demands

While performing the duties of thisjob 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 25 pounds. Specific vision abilities required by thisjobincludeclose vision and distance vision.

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

The position may require travel of up to 10%.

Work Environment

The noise level in the work environment is usually moderate.

#LI-Onsite

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.

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.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to. Visit access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: Protection

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