Global Quality & Compliance Lead - EU & Global

CSL Vifor; Milano; Hybrid; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid work model

Global exposure

Professional development

Flexible working arrangements

Competitive compensation

Job summary

CSL Vifor seeks a Quality Manager (m/f/x) to join Affiliate Quality Operations across Europe and global affiliates.

You will lead quality system governance, inspection readiness, and continuous improvement in collaboration with Quality, Regulatory, Pharmacovigilance, Manufacturing and Compliance teams. Reporting to the Affiliate Quality Head, you will drive KPIs, CAPA, and procedure harmonization across a complex international network with occasional travel.

Qualifications

• Bachelor's degree in Life Sciences or related field; other backgrounds considered with experience.
• Minimum 2 years in a pharmaceutical GxP-regulated role.
• Strong knowledge of quality systems, compliance processes, and ICH/regulatory standards.
• Ability to work independently and own projects with minimal supervision.
• Excellent interpersonal skills for global cross-functional work.
• Strong organizational, communication and stakeholder management skills.
• Identify and implement practical process improvements.
• Knowledge of CAPA processes and quality system methods preferred.
• Experience with electronic quality systems and digital tools is advantageous.
• Proficient in MS Office; exposure to SAP/Veeva/TrackWise/SharePoint desirable.
• Excellent written and spoken English; travel may be required.

Responsibilities

• Establish and maintain reporting processes for Quality KPIs across global affiliates.
• Coordinate inspection readiness activities throughout the network.
• Maintain compliance of policies, SOPs, and related documentation.
• Integrate Affiliate Quality SOPs with Global CSL procedures.
• Provide quality support to US Commercial Operations as needed.
• Support Product Technical Complaint activities for US market.
• Support Global Change Control, Deviation, and CAPA processes.
• Lead/participate in product release activities for US market and export products.
• Lead or support global electronic quality systems (SAP, MDC, DocNet).
• Ensure clear communication with stakeholders on progress and risks.

Skills

Quality systems

GxP-regulated

Stakeholder management

Project management

Communication

CAPA knowledge

Digital quality tools

English proficiency

Education

Bachelor's degree in Life Sciences

Tools

SAP

Veeva

TrackWise

SharePoint

Job description

CSL Vifor seeks a Quality Manager (m/f/x) to join Affiliate Quality Operations across Europe and global affiliates.

You will lead quality system governance, inspection readiness, and continuous improvement in collaboration with Quality, Regulatory, Pharmacovigilance, Manufacturing and Compliance teams. Reporting to the Affiliate Quality Head, you will drive KPIs, CAPA, and procedure harmonization across a complex international network with occasional travel.