EU-Based Global Quality & Compliance Lead (Hybrid)

CSL Plasma Inc.; Milano; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid working

Global exposure

Professional development

Competitive compensation

Job summary

CSL Plasma seeks a Quality Manager to drive global quality KPIs across affiliates, support inspection readiness, and maintain compliance with QMS. The role requires expanding the integration of Affiliate Quality SOPs with CSL procedures and enabling updates to meet local needs.

You will work with internal teams to ensure effective governance and document control. The candidate should have a Life Sciences degree and at least two years in a GxP pharma role, with strong English and cross-functional

Qualifications

• Bachelor’s degree in Life Sciences or related field; other backgrounds with relevant experience welcome.
• Minimum 2 years in a pharmaceutical GxP-regulated role.
• Strong knowledge of quality systems, compliance processes, and pharma regulations.
• Ability to work independently and deliver results with minimal supervision.
• Excellent cross-functional and stakeholder management skills.

Responsibilities

• Establish and maintain reporting processes for Quality KPIs across global affiliates.
• Coordinate inspection readiness activities within the global affiliate network.
• Support QMS compliance activities and keep policies and SOPs current.
• Integrate Affiliate Quality SOPs with Global CSL procedures and updates.
• Provide quality support to US Commercial Operations as required.
• Support Product Technical Complaint activities for the US market.
• Assist Global Change Control, Deviation, and CAPA processes.
• Lead or support product release activities for US market and exports.
• Lead global electronic quality systems implementation (SAP, MDG, DocNet).
• Maintain clear communication with stakeholders on progress, risks, and compliance.

Skills

Quality systems knowledge

CAPA development

Stakeholder management

Cross-functional collaboration

Communication in English

Education

Bachelor's degree in Life Sciences or related field

Tools

SAP

Veeva

TrackWise

SharePoint

Quality databases

Job description

CSL Plasma seeks a Quality Manager to drive global quality KPIs across affiliates, support inspection readiness, and maintain compliance with QMS. The role requires expanding the integration of Affiliate Quality SOPs with CSL procedures and enabling updates to meet local needs.

You will work with internal teams to ensure effective governance and document control. The candidate should have a Life Sciences degree and at least two years in a GxP pharma role, with strong English and cross-functional