Senior IM CSV Quality Lead - Global Validation Strategy

Leiden Bio Science Park; Netherlands; On-site; EUR 110,000 - 160,000; Full time

Job summary

Johnson & Johnson is seeking a Sr. Manager - IM Computer System Validation Quality Lead to drive strategy and governance for CSV and AI usage in GxP-regulated activities.

You will oversee lifecycle validation, risk-based approaches, and data integrity practices, while leading a global network of CSV leads and ensuring compliance across IM systems. The role emphasizes collaboration with QA/QMS/IT and cross-functional teams, delivering training and continuous improvement in validation

Qualifications

• University/Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field.
• 10+ years experience in Manufacturing/Quality in pharma.
• Experience with CSV in GxP-regulated environments.
• Knowledge of Annex 11 / 21 CFR Part 11.
• Leadership in global or cross-site roles.
• Experience with QRM, CAPA, Change Control.
• Strong communication and project management skills.

Responsibilities

• Act as CSV quality single point of contact for IM.
• Onboards and supports CSV framework in IM.
• Drive harmonization of CSV practices across IM.
• Oversee validation across lifecycle from planning to maintenance.
• Define and monitor KPIs for validation effectiveness.
• Lead a global network of CSV leads and provide training.
• Promote compliance culture and continuous improvement.

Skills

CSV validation

Data integrity

Quality systems

Risk management

Project management

Leadership

Regulatory compliance

Communication

Global leadership

SDLC/SLCM

Education

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

Master's degree preferred

Job description

Johnson & Johnson is seeking a Sr. Manager - IM Computer System Validation Quality Lead to drive strategy and governance for CSV and AI usage in GxP-regulated activities.

You will oversee lifecycle validation, risk-based approaches, and data integrity practices, while leading a global network of CSV leads and ensuring compliance across IM systems. The role emphasizes collaboration with QA/QMS/IT and cross-functional teams, delivering training and continuous improvement in validation