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

CSL; Milano; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid working model

Global exposure

Continuous learning opportunities

Job summary

CSL Behring in Milan seeks a Quality Manager (m/f/x) EU-based to lead affiliate quality operations across Europe, ensuring compliance with ICH, global CSL standards and inspection readiness.

You will collaborate with Quality, Regulatory, Pharmacovigilance, Manufacturing and Commercial teams, drive CAPA, change control, and the harmonization of quality systems in a complex international environment.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum of 2 years' experience in a pharmaceutical industry GxP-regulated role.
• Strong knowledge of quality systems, compliance processes, and regulatory guidelines such as ICH.

Responsibilities

• Establish and maintain reporting processes for Quality KPIs across global affiliates.
• Coordinate inspection readiness activities throughout the global affiliate network.
• Support QMS compliance activities, updating policies, SOPs, and related documentation.

Skills

Quality systems

CAPA

Quality governance

GxP

SAP

Veeva

TrackWise

SharePoint

Stakeholder management

Inspection readiness

Education

Bachelor's degree in Life Sciences

Alternative education accepted

Tools

SAP

Veeva

TrackWise

SharePoint

Job description

Entity: CSL Behring

Job Category: Quality

Job Family: Quality Control

Job Type: Full Time

Location: Milan, Milano, Italy

Employer Reference: R-284721

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

• 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.
• 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.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well‑being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

Equal Opportunity Employer CSL is an Equal Opportunity Employer.

If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.