Sr. Manager - IM CSV Quality lead

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We provide an inclusive work environment where each person is considered as an individual.

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Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium, Cork, Cork, Ireland, Fuji, Shizuoka-Ken, Japan, Geel, Antwerp, Belgium, Ghent, East Flanders, Belgium, Latina, Italy, Leiden, Netherlands, Raritan, New Jersey, United States of America, Schaffhausen, Switzerland, Wilson, North Carolina, United States of America, Xian, Shaanxi, China

Job Description:

The IM Computer System Validation (CSV) Quality Lead is responsible for assessing, implementing, and continuously improving the IM strategy for computer system validation and the use of embedded AI technology supporting GxP-regulated activities.

This role ensures oversight that all IM systems are validated and maintained in a validated state and are NOT using prohibited AI technology throughout their lifecycle, in alignment with global regulatory requirements (e.g., EU GMP Annex 11, FDA 21 CFR Part 11, Annex 22) and J&J quality standards.

The role inventories all IM systems, embedding the collection as an integral of the QMS.

It provides direction, oversight, and strategic direction across IM and platforms, ensuring consistent application of risk-based validation approaches, proper AI technology usage, robust data integrity practices (ALCOA+), and lifecycle management of computerized systems.

This position may be based at any of the listed locations or another relevant J&J IM Supply Chain site.

Key Responsibilities:

The Sr.

Manager - IM Computer System Validation Quality Lead is accountable and responsible for;


* Acting as IM Quality single point of contact for CSV, ensuring appropriate and timely communication of significant/critical quality and compliance issues linking to Computer System Validation and making recommendations for improvements to relevant senior level stakeholders.


* IM CSV Strategy & Governance
+ Onboards and supports the J&J enterprise CSV framework in IM aligned with regulatory expectations and internal quality systems,
+ Deploys standards for lifecycle validation, risk-based approaches, and system classification across IM,
+ Ensure consisten...