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

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

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

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:

• 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

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. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

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. 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 click here.

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