Global Quality Operations Lead

CSL Plasma Inc.; Italia; Hybrid; EUR 85,000 - 115,000; Full time

Benefits offered by this job

Hybrid work model

Exposure to international stakeholders

Job summary

CSL Plasma Inc. is seeking a Quality Manager (m/f/x) based in Europe to ensure the Affiliate Quality Management System across Europe and global affiliates remains compliant and fit for purpose.

You will lead inspection readiness, governance, and process harmonization, working with Quality, Regulatory, PV, and manufacturing colleagues to drive global quality initiatives. The role follows CSL's hybrid working model.

Qualifications

• Minimum of 2 years' experience in a pharmaceutical industry GxP-regulated role.
• Strong knowledge of quality systems, compliance processes, and pharma regulations (ICH).
• Ability to work independently and influence global teams.

Responsibilities

• Establish and maintain Quality KPI reporting for global affiliates.
• Coordinate inspection readiness activities across the affiliate network.
• Support CAPA, Change Control, Deviation, and QA documentation updates.
• Assist product release activities for US market and export products.

Skills

GxP experience

Quality systems

Stakeholder management

Cross-functional collaboration

Project management

English communication

Education

Bachelor's degree in Life Sciences

Tools

SAP

Veeva

TrackWise

SharePoint

Job description

CSL Plasma Inc. is seeking a Quality Manager (m/f/x) based in Europe to ensure the Affiliate Quality Management System across Europe and global affiliates remains compliant and fit for purpose.

You will lead inspection readiness, governance, and process harmonization, working with Quality, Regulatory, PV, and manufacturing colleagues to drive global quality initiatives. The role follows CSL's hybrid working model.