IM CSV Quality Lead: Validation Strategy & AI Compliance

360Pharma; Belgique; On-site; EUR 120,000 - 150,000; Full time

Job summary

360Pharma is seeking a senior leader for IM CSV Quality Lead to oversee validation and lifecycle management of GxP-relevant systems, ensuring compliant AI usage and robust data integrity. You will drive risk-based validation, lifecycle governance, and supplier oversight across global sites.

The role requires extensive CSV experience, leadership across cross-site teams, and strong communication with QA, IT, and manufacturing functions to sustain regulatory readiness.

Qualifications

• Experience leading CSV programs within a GxP-regulated environment.
• Strong knowledge of data integrity principles (ALCOA+) across systems.
• Familiarity with regulatory requirements (EU Annex 11, 21 CFR Part 11) and ISO standards.

Responsibilities

• Act as IM CSV Quality single point of contact for CSV issues and improvements.
• Onboard and support enterprise CSV framework and lifecycle validation.
• Define risk-based validation approaches and oversee SDLC/SLCM activities.
• Ensure systems are validated, maintained, and properly retired.
• Lead global CSV network and provide training for IM CSV roles.
• Drive continuous improvement and alignment with digital transformation.

Skills

CSV leadership

GxP compliance

Data integrity

Quality management

Regulatory knowledge

Project management

Stakeholder communication

Risk-based validation

Education

Bachelor's or higher in Life Sciences/Engineering/CS

Job description

360Pharma is seeking a senior leader for IM CSV Quality Lead to oversee validation and lifecycle management of GxP-relevant systems, ensuring compliant AI usage and robust data integrity. You will drive risk-based validation, lifecycle governance, and supplier oversight across global sites.

The role requires extensive CSV experience, leadership across cross-site teams, and strong communication with QA, IT, and manufacturing functions to sustain regulatory readiness.