Sr. Manager, Compliance and Quality Risk Management
Sr. Manager, Compliance and Quality Risk Management
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Job Description
Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: 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
Bachelors 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 knowledge and proven experience in applying risk management tools and methods (e.g. FMEA PHA HAACP Risk Ranking and Filtering)
Candidate must be familiar with and be able to interpret relevant regulations regulatory agency inspection expectations e.g. FDA EMEA Health Canada etc.
Demonstrated leadership communication and motivation skills
Demonstrated strong interpersonal abilities through experience at a global organization (ie. relationship building listening negotiation and conflict management).
Excellent communication skills.
Demonstrated ability to write clearly and concisely.
Ability to balance multiple assignments in a fast-paced environment
Ability to lead and direct change via influence rather than direct control
Ability to drive collaborations across functions to accomplish objectives
Ability to design and propose solutions that address identified needs and opportunities
Ability to solve moderately complex problems independently (e.g. selecting appropriate participants method and facilitation approach for a large-scale risk assessment)
Preferred:
Knowledge of radiopharmaceutical manufacturing and analytical testing is highly desirable
This is a position that requires working in a laboratory environment protective clothing gloves and safety glasses are required while working in a laboratory environment with radioactive materials.
WorkEnvironment
The noise level in theworkenvironment is usually moderate.
#RayzeBio GPS2025 #LI-Onsite
If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical pharmacy dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability life insurance supplemental health insurance business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours flexibility. Parental caregiver bereavement and military leave. Family care services such as adoption and surrogacy reimbursement fertility/infertility benefits support for traveling mothers and child elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Manager
Employment Type
Full-Time
