Want to know if this job is worth applying to?
Indianapolis - RayzeBio - IN, United States of America
Onsite
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/
The Senior Manager, Operations QA is a key role in the Quality Assurance team at the RayzeBio Indianapolis manufacturing site. This is a people manager position with supervisory responsibilities for up to 8 direct reports. The Operations Quality Assurance team is responsible for Quality collaboration and GMP/GDP oversight of operations at CDMOs and at Internal site operations, including but not limited to manufacturing, testing, packaging, labeling, and warehouse operations, including incoming material management.
The Senior Manager, Operations Quality Assurance, RayzeBio is responsible for the cGMP/GDP activities at CDMOs and at the Indianapolis site in accordance with RayzeBio policies, standards, procedures, and the regulatory requirements (US, EU, ICH etc.). Functional responsibilities include ensuring operational compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.
The Senior Manager, Operations Quality Assurance role is located in Indianapolis, IN, and reports to the Site Quality Lead of the RayzeBio Indianapolis manufacturing site.
Key Responsibilities
Provide leadership to ensure routine Operations Quality oversight and to ensure collaborative triages of unexpected events within the Manufacturing, Quality Control Labs, and Supply Chain operational areas and systems.
Have a comprehensive understanding of Radio-Pharma manufacturing processes to enable real-time decision-making.
Advanced ability to synthesize information from multiple sources, interpret problems and effectively communicate to cross-functional management in a clear, brief, and accurate manner.
Respond to complex/critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to stop/continue manufacturing
Serve as a subject matter expert supporting others to navigate the RayzeBio quality management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and batch record management.
Evaluate, author, and/or review operating procedures (e.g., policies, SOPs, Wis) and perform other activities in support of quality operations.
Provide direction and timely guidance to the staff regarding the handling and resolution of cGMP events which may be a part of deviations, batch record exceptions, and other quality operational challenges.
Accountable for the performance/delivery of the QA field quality organization, including oversight of the “QA on-the-floor” systems and programs that enable the highest quality and the quickest delivery of QA cGMP tasks.
Develop and implement standard-work for team-members that balances on-floor support for non-routine events, routine quality assurance work, and stretch/development project work.
Assist in developing quality KPI/metrics to support GxP activities and/or for management reviews
Responsible for establishing, expanding, and maintaining RayzeBio GMP compliance program and building a positive quality culture at RayzeBio Indianapolis site.
Champion a culture that embraces psychological and physical safety of employees in the work environment.
Champion a culture of teamwork, communication, and continuous improvement focused on defining problem statements, driving initial investigative efforts, and actioning solutions to reduce recurrence.
Proactively identify and address quality risks and critical issues, drive mitigations with the aid of Field Quality Staff and cross-functional partners and escalate to senior management as needed.
Lead walkthroughs with peers or QA team-members to identify and remediate operational or quality issues.
Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.
Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge
Regularly spend time coaching and mentoring operators and Field QA specialists while on the manufacturing floor.
Interview, hire, coach, motivate, and develop exceptional staff. Set performance objectives and development plans. Monitor performance progress and actively lead and conduct performance reviews for all direct reports.
Applies AI to improve team execution and decision‑making.
Qualifications & Experience
Bachelor's degree in STEM field preferred.
High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
10+ years of relevant cGMP experience, preferably with 5+ years of QA shop floor and/or QA operations
Ability to lead on-site quality operations teams
Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.
Experience working in aseptic/sterile environments and/or in quality control operations focused on microbial controls and contamination mitigation strategies is preferred.
Experience in FDA/EMA regulations in biopharmaceuticals, cell/gene therapy, and/or radio-pharmaceutical manufacturing is required.
Demonstrated experience working with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or Quality Management Systems such as TrackWise or Veeva.
Advanced ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
Excellent written and verbal skills and advanced ability to present technical data effectively based on target audience
Ability to work in a fast-paced team environment and lead peers through changing priorities
Ability to think strategically, meet deadlines, and support work prioritization
Ability to negotiate and influence to craft mutually beneficial solutions
Ability to motivate and foster a positive team environment
Ability to lead change in a fast-paced environment with limited information and/or time constraints.
Exhibit strong decision-making and ability to think creatively while maintaining compliance and quality
Pioneering mindset and ability to create innovative solutions
Ability to think strategically, with an enterprise-mindset, establish deadlines and prioritize work according to the needs of the business and within budget.
Ability to research, understand, interpret, and apply internal policies, cGMP, and quality principles.
Establishment of strategic goals, departmental objectives, and motivating team to achieve operational tasks.
Proactively finds solutions to quality and operational problems by creative thinking and innovative solutions.
Proven ability to negotiate mutually beneficial solutions and resolve differing perspectives among stakeholders.
Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications.
Ability to work within pharmaceutical cleanroom environments.
Working Conditions:
Able to work near processing/handling of hazardous materials; including radioactive materials.
This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials. Able to gown for clean rooms such as ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, etc.).
While performing the duties of this job, 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 30 pounds. Specific vision abilities required by this job include close vision and distance vision.
The noise level in the work environment is usually moderate. Work-related travel (outside of Indianapolis, Indiana) may be required up to 20% of working time (e.g., 10 weeks per year).
If you come across a role that intrigues you but doesn’t 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.
Compensation Overview:
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 employee’s 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 https://careers.bms.com/life-at-bms/.
Benefit 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 workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to 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: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection/
Any 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 TAEnablement@bms.com. 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.
R1603823 : Senior Manager - QA Operations