Associate Director, Quality Systems

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: Associate Director Quality Systems is responsible for operational oversight and maintenance of the Indianapolis site Quality Management System for RayzeBio. This includes establishment continuous improvement and ensuring the consistent implementation of global quality system policies in the GMP spectrum. This position will report to the Director RayzeBio Quality Systems & Compliance and oversee GMP quality systems at RayzeBio Indianapolis site. The position may require Quality oversight of one or more enterprise quality systems (e.g. training document retention).

Job Responsibilities

• Leads/supports implementation of GxP Quality Systems at RayzeBio Indianapolis site; including implementation of electronic systems as needed.

• Leads/supports oversight of Quality Assurance Systems including Deviations and Investigations; Corrective and Preventive Actions; Product Complaints; Change Control; Document Control; Document Retention and GxP Training

• Ensure that the Indianapolis site is always ready for audits and health authority inspections. Ability to host the audit/inspection (front and/or back room). Actively contribute as required to all audits/inspections.

• Ensure creation and implementation of the following at the Indianapolis site

  Self-inspection program/process

  GMP regulatory surveillance at the Indianapolis site

  Health authority communication (GMP only) such as field alerts APQR etc.

• Evaluate author and/or review operating procedures (e.g. policies SOPs etc.) and perform other activities in support of an integrated cross-functional quality management system (QMS).

• Assist in developing quality/KPI metrics/reports to support GxP activities Quality council meetings and/or management review.

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

• Provides oversight to identify and implement changes that lead to realization of long-term department and company goals.

• Regularly communicates ongoing/upcoming electronic QMS activities to broader RayzeBio (e.g. via monthly newsletter).

• Supervise up to six direct reports

• Other QA specific responsibilities as assigned by QA management

Education and Experience:

• At minimum a bachelors degree in engineering or a life or physical science related field (including biology biochemistry chemistry) is required.

• Minimum 7-10 years in GxP (GMP GLP GCP) pharmaceutical or other regulated environment demonstrating progressive increase in responsibility. Highly desirable to have a minimum of 5 years of Quality Systems experience.

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

• Knowledge and proven experience in hosting/facilitating FDA EMA or other regulatory authority inspections.

• Ability to successfully solve challenging issues critical thinking and detail oriented

• Strong interpersonal verbal and written communication skills

• Demonstrable record of strong leadership and teamwork in a cross-functional industry environment.

• Excellent written and verbal communication skills.

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

• Demonstrated prioritization and organization skills.

• Previous experience implementing and developing quality systems is required

• Previous experience in directly dealing with health authority inspectors is preferred but not required

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%.

WorkEnvironment

The noise level in theworkenvironment is usually moderate.

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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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