Manager, QA Compliance

Bristol Myers Squibb • Indianapolis, IN

1d

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 QA Compliance provides management of activities for Site Quality Operations in accordance with RayzeBio policies, standards, procedures and global cGMPs. In addition, the role will be responsible for the Change Controls Review Board, Complaints, Data Integrity, Quality Council, and other Quality metrics

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
• 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

• Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired.

Responsibilities

• Implements and Manages the Change Control Quality System for all GMP activities and works with responsible cross functional areas ensure timely completion.
• Run the Change Control Review Boards, generate meeting minutes, follow up on action items and facilitate resolution when required.
• Communicates effectively with cross functional stakeholders on matters related to change control process.
• Implements and manages the necessary investigations and CAPA review boards at a timely manner.
• Responsible for the site Quality Council program and acts as Quality Council Lead
• Develops and Maintains Quality Metrics to monitor compliance
• Collaborates with stakeholders to develop appropriate actions to resolve quality system issues
• Leads site Data Integrity Program
• Responsible for complaints
• 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.
• Other QA specific responsibilities as assigned by QA management
• Applies AI to improve team execution and decision‑making

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.

What This Job Offers

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