Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary

The Senior Manager, Compliance and Quality Risk Management at RayzeBio serves as the Local Process Owner for Risk Management and Data Integrity, responsible for driving consistent, compliant, and risk-based practices across the site. This leadership role ensures alignment with global policies, internal standards, and regulatory expectations while fostering a culture of risk awareness and data integrity. This role provides strategic direction, mentoring, and subject-matter expertise to site teams, promoting the adoption of Quality Risk Management (QRM) principles and building capability across the organization. The role leads the RayzeBio site QRM governance forum and facilitates complex, cross-functional risk assessments, ensuring timely escalation and reporting of risk information to senior leadership.  This role also maintains the site risk register, reviews and approves SOPs, and supports regulatory inspections. Through metrics reporting and active participation in the site Quality Council, this role ensures transparency, accountability, and continuous improvement in compliance and risk management practices.

Job Responsibilities

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

·Provide subject-matter expertise and consultation to risk assessment teams at the site

·Personally facilitate complex or highly cross-functional risk assessments

·Manage the escalation and reporting of risk information to management

·Develop and deliver training on QRM concepts, methods and regulatory expectations

·Act independently to determine methods and procedures on new assignments.

·Ensures documentation integrity and compliance, manages the Site Risk Register, and provides regular risk reporting with both qualitative and quantitative insights.

·Lead data integrity assessments to ensure compliance with regulatory and internal data integrity requirements.

·Lead and review remediation efforts for identified data integrity gaps, ensuring timely and effective resolution.

·Oversee data creation, processing, review, reporting, and traceability to ensure accuracy and reliability.

·Conduct regular reviews of implemented systems and monitor risks to ensure ongoing compliance.

·Participate in inspections and coordinate responses related to data integrity.

·Serve as the quality authority for data integrity-related activities, ensuring alignment with corporate standards and industry best practices.

Education and Experience

·Bachelor’s degree in a scientific or engineering discipline, or its equivalent is required.

·A minimum of 10 years of relevant experience including experience working within or supporting a GxP-regulated function

Skills and Qualifications

Required:

·Expertise in ICHQ9 and Quality Risk Management Program Implementation is required

·Strong knowle