Manager, Quality Engineering

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 Manager for Quality Engineering will be responsible for providing Quality oversight of qualification and validation activities and change control for the startup and continuing operations of the RayzeBio Indianapolis facility, including commissioning, qualification, and validation of equipment, preventive maintenance and calibration activities, and process validation per established local and global standards.

Job Responsibilities

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

• Review and approve commissioning and qualification lifecycle documentation associated with manufacturing site facilities/equipment/and utilities, including but not limited to system/component impact assessments, user requirements, configuration specifications, installation/operational qualification, performance qualification, requalification etc.

• Ensure compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Commissioning/Qualification and Validation teams. Includes Quality input and oversight to fundamental facility start-up activities such as environmental monitoring performance qualification, utility qualification, and aseptic (or media) process simulation/validation

• May participate in and review/approve risk assessments, data integrity assessments, and technical reports supporting qualification

• Assure appropriateness of calibration/maintenance programs, validation plans, qualification or requalification protocols, associated reports and procedures.

• Perform routine quality review/approval activities associated with equipment/system onboarding and status

• Identify improvement opportunities and support execution of team continuous improvement goals and projects

• May review and approve or provide impact assessment for site change controls

• Participates as a core team member in any corporate or health authority inspections.

• 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 teams and cross-functional project teams and drives team performance and results. Contributes highly to departmental performance and quality initiatives; able to conceptualize impact of Quality initiatives in terms of cross-functional teams.

• Applies AI to improve team execution and decision‑making

• Other QA specific responsibilities as assigned by QA management

Education and Experience:

• At minimum, Associate's Degree, in engineering or a life or physical science-related field (including biology, biochemistry, chemistry) is required. 

• Minimum 5 years of direct validation-related experience, or equivalent expertise. 

• Familiarity with Quality Risk Management principles is valuable.

• Knowledge of US, 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, 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 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. Speci