Manager, IT Validation Services
About The Position
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.
Requirements
- Bachelor’s degree in a STEM or related discipline.
- 6+ years’ relevant experience.
- 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.
Nice To Haves
- Cross-functional experience in one or more regulated areas (i.e. Cell Therapy, Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is desired.
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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
