Manager, GMP Inspection Management

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: Manager GMP Inspection Management provides management of activities for Site Quality Operations in accordance with RayzeBio policies standards procedures and global addition the role will be responsible for the Self-Inspection Program Pre-Licensure Inspection Readiness Audits QP audits and Health Authority Inspections.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned as required.

• Leads site inspection readiness efforts about preparing the Indianapolis site for health authority inspections and internal corporate audits.
• Develop and manage the Inspection Readiness annual plan including identification of anticipated inspections.
• Participates as a core team member in any corporate or health authority inspections and leads cross functional teams to develop responses tracking the commitments to completion.
• Responsible RayzeBio Self-Inspection Program. May conduct audits of RayzeBio departments relative to RayzeBio policies and procedures as well as the relevant Health Authority requirements.
• Leads Regulatory Surveillance activities including identifying impacted functions driving impact assessments and proactive action plans
• Provides compliance expertise and guidance to the site on applicable regulatory cGMP and corporate requirements.
• Supports regulatory agency correspondence and filing submission activities.
• Leads Fact Finding deliverables for significant events and supports Field Alert Reporting submissions as required.
• Leads APQR document coordination and authoring support for site
• Identifies and reports discrepancies from required work practices or procedures to management.
• 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.
• 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 5-7 years of work experience in Quality Assurance and minimum 4 years of direct QA experience in leading/hosting/conducting GMP audits/inspections.
• 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 hosting/facilitating FDA EMA or other regulatory authority inspections.
• Demonstrated leadership interpersonal communication and motivation skills.
• Excellent writing and oral communication skills are required.
• Previous work responsibility which required a high degree of attention to detail.
• Well-practiced in exercising sound judgment in decision-making.
• 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 occasional travel but not more than 5%.

WorkEnvironment

The noise level in theworkenvironment 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

We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way please contact BMS at . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response.