Computer System Validation Csv Remote Jobs in California

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/

Job Title: Sr. Manager, RIM Systems and Publishing

Department: Regulatory

Location: Remote

FLSA Status: Exempt

Job Responsibilities

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

• Serve as a business administrator and business owner for Veeva Vault RIM platforms (Submissions, Submissions Archive, and Publishing).
• Lead Veeva Vault RIM governance, optimization, end-user support, and continuous improvement of Regulatory Operations processes through effective use of Veeva Vault RIM.
• Maintain and govern RIM master data, metadata standards, controlled vocabularies, relationships, and business rules to ensure data integrity, consistency, traceability, reporting accuracy, publishing readiness, and inspection readiness.
• Lead Vault Publishing administration and assist with validation and implementation.
• Support submission leads with content plan development, publishing configuration, workflows, publishing rules, validation, troubleshooting, and submission readiness activities
• Develop and deliver system training, SOPs, work instructions, job aids, process flows, and governance documentation.
• Partner with IT and Quality, as applicable, to support release management, system validation, change control, user access management, and compliance requirements.
• Develop and maintain system metrics, dashboards, and reports to support operational oversight, compliance monitoring, data quality, and leadership decision-making.

• Maintain current knowledge of Veeva Vault RIM functionality, regulatory submission requirements, electronic publishing standards, and industry best practices.
• Perform and/or support submission publishing activities as needed to support business priorities and resource demands.

Education and Experience

• Bachelor's degree with 8+ years of relevant experience in regulatory systems or regulatory operations.

• Hands-on experience administering and supporting Veeva Vault RIM applications, including Submissions, Submissions Archive, and Publishing
• Experience with eCTD publishing solutions and regulatory submission workflows.
• Experience supporting Veeva RIM Publishing implementation preferred.

Skills and Qualifications

• Strong understanding of regulatory submission processes, eCTD structure, publishing requirements, and submission lifecycle management.
• Strong understanding of data governance, metadata management, document classification, and inspection readiness principles.
• Ability to translate business requirements into practical system processes and governance standards.
• Strong troubleshooting skills for complex system, publishing, and process issues.
• Ability to train and support end users with varying levels of system experience.
• Highly organized, with the ability to manage system initiatives, governance activities, user support, and operational priorities.
• Ability to collaborate effectively with Regulatory Affairs, IT, Quality, vendors, and cross-functional business users.
• Proactive, professional, and confident.

• Excellent professional ethics and integrity.

Physical Demands

While performing the duties of thisjob, 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 15 pounds. Specific vision abilities required by thisjobincludeclose vision and distance vision.

#LI-REMOTE

If you come across a role that intrigues you but doesn't 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.

Remote - United States - US: $149,860 - $181,595

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 employee's 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 https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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.

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries toadastaffingsupport@bms.com. Visitcareers.bms.com/eeo-accessibilityto access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio 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:https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response.

R1605077 : Sr. Manager, RIM Systems and Publishing