Sr. Manager - IM CSV Quality Lead

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Quality

Quality Systems

Professional

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

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.

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

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 consistent interpretation and application of Annex 11 requirements across sites,
  • Drive harmonization of CSV practices across IM and business units.
• Lifecycle Validation Oversight of all IM GxP-relevant computerized systems
  • Validated prior to use,
  • Maintained in a validated state throughout their lifecycle,
  • Properly retired/decommissioned,
  • Oversee validation activities across IM system lifecycle (planning → design → testing → release → maintenance),
  • Define and monitor KPIs for validation effectiveness and compliance.
• Data Integrity & Compliance
  • Ensure implementation of data integrity principles (ALCOA+) across all systems and processes,
  • Ensure compliance with J&J CSV and Data Integrity standards.
• Risk-Based Validation & QRM
  • Define and enforce risk-based validation approaches using Quality Risk Management (QRM),
  • Ensure appropriate validation effort proportional to system criticality and GxP impact,
  • Oversee system risk assessments and mitigation strategies in IM.
• IM System Lifecycle & Technical Compliance
  • Guides and oversees System Development Lifecycle (SDLC) / System Lifecycle Management (SLCM) activities (incl. system periodic review activities and follow-ups).
• Supplier & Third-Party Oversight
  • Onboards and…