Global Quality Manager (mfx) EU-based

Location: Warsaw Prague Barcelona Stockholm Copenhagen Vienna Budapest or Milan

Employment: Full-time Permanent

You will be a key member of the Affiliate Quality Operations organization supporting the effectiveness compliance and continuous improvement of CSLs 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:

• Bachelors 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:

• 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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 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 and CSL Plasma at 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 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 Experience:

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