Quality Manager (m/f/x) - EU-based

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

Quality Manager (m/f/x) - EU-based

Location: Open to candidates based in countries where CSL has an affiliate presence, provided they are located within commuting distance of a CSL office and can attend the workplace in line with CSL's return-to-office policy.

Employment: Full-time, Permanent

You will be a key member of the Affiliate Quality Operations organization, supporting the effectiveness, compliance, and continuous improvement of CSL's Affiliate Quality Management System across Europe and global affiliates.

In this role, you will partner with Quality leaders, business process owners, and stakeholders across multiple functions to ensure policies, procedures, and quality systems remain compliant, fit for purpose, and aligned with regulatory requirements and CSL standards. You will play a critical role in inspection readiness, quality system governance, process harmonization, and the implementation of global quality initiatives.

This position offers the opportunity to influence quality practices across a complex international environment while collaborating with colleagues from Quality, Regulatory Affairs, Pharmacovigilance, Commercial Operations, Manufacturing, Compliance, and other business functions.

The Role:

Reporting to the Affiliate Quality Head, US & Quality Systems, Standards & Governance, you will:

• Establish and maintain processes for reporting Quality KPIs across global affiliates.
• Coordinate inspection readiness activities throughout the global affiliate network.
• Support quality management system compliance activities, ensuring policies, SOPs, work instructions, and related documentation remain current, effective, and aligned with business and regulatory requirements.
• Manage the integration of Affiliate Quality SOPs with Global CSL procedures and facilitate procedure updates to incorporate affiliate and local requirements.
• Provide quality support to US Commercial Operations as required.
• Support Product Technical Complaint (PTC) activities for the US market.
• Support Global Change Control, Deviation, and CAPA processes across assigned regions.
• Support and perform product release activities for the US market and Kankakee-manufactured export products, collaborating with manufacturing site representatives as needed.
• Lead and/or support implementation of global electronic quality systems such as SAP, Master Data Governance, and DocNet.
• Ensure effective communication with internal and external stakeholders regarding progress, improvements, risks, and compliance-related matters.

Your Skills and Experience:

• Bachelor's degree in Life Sciences, a Scientific Discipline, Project Management, Business Management, or a related field. Candidates with alternative educational backgrounds and significant relevant experience will also be considered.
• Minimum of 2 years' experience in a pharmaceutical industry GxP-regulated role.
• Strong knowledge of quality systems, compliance processes, and pharmaceutical industry regulations, including ICH guidelines and industry standards.
• Demonstrated ability to work independently, take ownership of assigned projects, and deliver results with minimal supervision.
• Excellent interpersonal skills with the ability to build effective cross-functional relationships and work successfully within global teams.
• Strong organizational, communication, influencing, and stakeholder management skills.
• Ability to identify process improvement opportunities and implement practical, innovative solutions.
• Working knowledge of CAPA development and quality system methodologies is preferred.
• Experience supporting or implementing electronic quality systems and digital quality tools is advantageous.
• Strong computer skills, including Microsoft Office applications. Experience with SAP, Veeva, TrackWise, SharePoint, collaboration tools, or quality databases is desirable.
• Excellent written and verbal communication skills in English.
• Limited travel may be required.

What we offer:

At CSL, we are committed to improving the lives of patients around the world while providing our employees with meaningful opportunities for growth and development. We offer:

• This role follows CSL's hybrid working model. Employees are expected to work from a CSL office in accordance with local return-to-office requirements and team needs.
• A collaborative, purpose-driven environment focused on innovation and quality.
• The opportunity to contribute to a global organization dedicated to saving and improving lives.
• Exposure to international stakeholders and diverse business functions across the CSL network.
• Professional development opportunities and support for continuous learning.
• Flexible working arrangements, where applicable.
• Competitive compensation and benefits programs.
• A culture that values inclusion, integrity, accountability, and high performance.
• Compensation: Salary ranges for this role differ by country and are aligned with local market conditions and legal requirements. Country-specific salary information will be shared as part of the recruitment process.