Global IM CSV Quality Lead | Senior Manager

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 96 000 - 165 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson is seeking a Sr. Manager - IM Computer System Validation Quality Lead to assess, implement, and improve CSV strategies across IM, ensuring validated systems and compliant data handling in line with EU GMP Annex 11 and FDA 21 CFR Part 11.

The role focuses on governance, risk-based validation, SDLC oversight, data integrity (ALCOA+), and building a global CSV team to drive continuous improvement and AI governance within GxP environments.

Qualifications

• No explicit bullet; the candidate should have extensive CSV experience in a GxP-regulated environment and regulatory knowledge.

Responsabilités

• Act as IM Quality single point of contact for CSV and communicate significant quality issues to senior stakeholders.
• Onboard and supports the J&J enterprise CSV framework in IM and align with regulatory expectations.
• Drive harmonization of CSV practices across IM and business units.
• Oversee validation activities across the IM system lifecycle (planning -> design -> testing -> release -> maintenance).

Connaissances

Analytical Reasoning

Analytics Dashboards

Compliance Management

Data Gathering and Analysis

Data Quality

Incident Management

Organizing

Performance Measurement

Quality Control (QC)

Quality Management Systems (QMS)

Quality Services

Quality Standards

Risk Management

Standard Operating Procedure (SOP)

System Integration

Systems Analysis

Tactical Planning

Technical Credibility

Formation

Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field

Master's degree preferred

Description du poste

Johnson & Johnson is seeking a Sr. Manager - IM Computer System Validation Quality Lead to assess, implement, and improve CSV strategies across IM, ensuring validated systems and compliant data handling in line with EU GMP Annex 11 and FDA 21 CFR Part 11.

The role focuses on governance, risk-based validation, SDLC oversight, data integrity (ALCOA+), and building a global CSV team to drive continuous improvement and AI governance within GxP environments.