Manager, IT Validation Services

Bristol Myers Squibb EU Policy; Princeton (NJ); On-site; USD 90,440 - 109,592; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

Financial Well-being and Protection

Paid Time Off

Job summary

Bristol Myers Squibb is seeking an experienced Manager, IT Validation Services to lead CSV efforts for enterprise GxP systems. You will collaborate with IT Delivery teams, business users and Global Quality to plan and execute validation with governance, data integrity and regulatory compliance.

This role embraces AI to accelerate creation, review and testing, promotes test automation and agile CSV practices, and requires strong communication across highly matrixed teams in a global environment.

Qualifications

• Bachelor’s degree in a STEM or related discipline.
• 6+ years’ relevant experience.
• Cross-functional experience in one or more regulated areas (i.e. Cell Therapy, Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is desired.
• Experience with electronic document management systems (e.g. Qumas, Veeva, SharePoint etc.); application development and lifecycle management (e.g. ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow)
• Experience with and/or ability to learn how to use AI as an accelerator for creation/review of documents and testing.
• Experience with test automation capabilities.
• Experience with agile CSV methodologies.
• Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
• Strong critical thinking to analyze complex situations and discern critical issues.
• Able to work effectively with highly-matrixed and multi-cultural workforce and build strong relationships by being transparent, reliable and delivering on commitments.
• Excellent interpersonal skills, including written and verbal communication.
• Strong sense of ethics, diplomacy and discretion.
• Commitment to Quality.
• Ability to manage competing priorities.

Responsibilities

• Defines and owns the IT CSV strategy and approach for enterprise GxP systems.
• Drives the CSV activities through to completion and acts as the CSV Subject Matter Expert (SME) accountable for the generation of CSV deliverables.
• Supports CSV for both COTS and custom-developed solutions, understanding the differences in CSV approaches for each and guides development/testing teams accordingly.

Skills

AI acceleration

Test automation

Agile CSV

Cross-functional collaboration

Critical thinking

Effective communication

Education

Bachelor’s degree in a STEM or related discipline

Tools

Qumas

Veeva

SharePoint

JIRA

ALM

ServiceNow

Job description

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.

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.

Position Summary

Leads and manages Computer System Validation (CSV) efforts for enterprise GxP systems used across multiple functional business organizations. Collaborates with IT Delivery teams, business users and internal Global Quality staff to ensure that CSV activities are planned and executed in accordance with internal procedures.
The role is expected to actively leverage AI as an accelerator for validation deliverables, requirements analysis, review efficiency, testing, and documentation quality, while applying appropriate governance, human oversight, and compliance expectations for GxP systems. The position also promotes the use of test automation, agile CSV practices, and other technical innovations to improve execution efficiency, consistency, traceability, and inspection readiness. This includes enabling risk-based, iterative validation approaches that align CSV activities with agile delivery models and maintain clear evidence of requirements, testing, approvals, and change control throughout the system lifecycle. As a change agent for the organization, this role helps identify, evaluate, and responsibly adopt new ideas and digital capabilities that modernize Computer System Validation practices while maintaining a strong commitment to quality, data integrity, and regulatory compliance.

Detailed Description

• Defines and owns the IT CSV strategy and approach for enterprise GxP systems.
• Drives the CSV activities through to completion and acts as the CSV Subject Matter Expert (SME) accountable for the generation of CSV deliverables.
• Supports CSV for both COTS and custom-developed solutions, understanding the differences in CSV approaches for each and guides development/testing teams accordingly.

Requirements

• Bachelor’s degree in a STEM or related discipline.
• 6+ years’ relevant experience.
• Cross-functional experience in one or more regulated areas (i.e. Cell Therapy, Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is desired.
• Experience with electronic document management systems (e.g. Qumas, Veeva, SharePoint etc.); application development and lifecycle management (e.g. ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow)
• Experience with and/or ability to learn how to use AI as an accelerator for creation/review of documents and testing.
• Experience with test automation capabilities.
• Experience with agile CSV methodologies.
• Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
• Strong critical thinking to analyze complex situations and discern critical issues.
• Able to work effectively with highly-matrixed and multi-cultural workforce and build strong relationships by being transparent, reliable and delivering on commitments.
• Excellent interpersonal skills, including written and verbal communication.
• Strong sense of ethics, diplomacy and discretion.
• Commitment to Quality.
• Ability to manage competing priorities.

Compensation Overview

Princeton - NJ - US: $90,440 - $109,592

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.

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.

Supporting People With Disabilities

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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: 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 [e-mail]. 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. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1604624 : Manager, IT Validation Services