Manager, Quality Engineering

Bristol Myers Squibb • Indianapolis, IN

1d • $124,449 - $150,803

About The Position

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.

Requirements

• 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 and minimum 3 years of direct validation-related experience, or equivalent expertise.
• 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.

Nice To Haves

• Familiarity with Quality Risk Management principles is valuable.

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees