IT Validation Services Lead | AI-Powered CSV for GxP

Bristol Myers Squibb EU Policy

Princeton (NJ)

On-site

USD 90,440 - 109,592

Full time

14 days+

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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.