Manager, Quality Systems

Summary The Quality Systems Manager is responsible for the establishment, maintenance, and continuous improvement of the QMS in accordance with RayzeBio policies, standards, procedures and global cGMPs. This position will help ensure QMS systems are designed, set up, and function in a GMP‑compliant manner. Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned as required. Maintains and provides oversight and support for activities using the various Quality Systems utilized at RayzeBio such as the electronic Document Management System, electronic Quality Management System, or interfaces with laboratory systems. Collaborates with stakeholders to develop appropriate actions to resolve quality system issues. Oversees quality system process support and compliance, not technical system administration. Provides input and quality approvals for validation documentation that supports enterprise systems or applicable site and/or globally owned systems. Reviews and approves documents, change controls, and protocols related to QMS systems. Provides governance, oversight, and approval of deviation investigations related to quality systems. Drafts, reviews, and edits SOPs, process flow and other business documentation. Manages project activities and ensures appropriate team members are assigned to appropriate activities. 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. Leads cross‑functional quality system initiatives and contributes to departmental quality objectives. Additional Quality Systems responsibilities consistent with role scope. Applies AI to improve team execution and decision‑making. Education and Experience At minimum, a bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry) is required. Minimum 5 years of work experience in Quality Assurance. Knowledge of U.S., EU and rest‑of‑world cGMP regulations and guidance. Demonstrated leadership, interpersonal, communication, and motivation skills. Excellent writing and oral communication skills are required. Previous work responsibility requiring 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 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 25 pounds. Specific vision abilities required by this job include close vision and distance vision. This position requires working in a laboratory environment; protective clothing, gloves, and safety glasses are required while working with radioactive materials. The position may require occasional travel, but not more than 5%. Work Environment The noise level in the work environment is usually moderate. Compensation Overview Location: Indianapolis, IN. The starting compensation range is $124,449 – $150,803. Additional incentive cash and stock opportunities (based on eligibility) may be available. Benefits Health Coverage: Medical, pharmacy, dental, and vision care. Well‑being Support: 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. Paid Time Off: US Exempt Employees: flexible time off (unlimited with manager approval) and 11 paid national holidays; additional time for non‑exempt employees as per local policies. Additional time off may include unlimited paid sick time, up to two 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 Year’s Day. Equal Employment Opportunity Bristol Myers Squibb is an equal‑opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation or other characteristics protected by law. #J-18808-Ljbffr