Global Quality & Compliance Manager - Hybrid

CSL

Wien

Hybrid

EUR 70,000 - 100,000

Full time

8 days ago
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Benefits offered by this job

Hybrid working model
Professional development opportunities
Global exposure
Competitive compensation

Job summary

CSL Vifor is seeking a Quality Manager (m/f/x) based in the EU to oversee affiliate quality operations across Europe and global affiliates. The role focuses on inspection readiness, governance of quality systems, and harmonization of processes in a complex international setting.

You will partner with Quality leaders across functions to ensure policies and SOPs are fit for purpose and regulatory compliant, while supporting global quality initiatives and product release activities for the US

Qualifications

  • Bachelor's degree in Life Sciences or related field.
  • 2+ years' experience in a pharma GxP-regulated role.
  • Strong knowledge of quality systems and regulatory requirements (ICH).
  • Excellent cross-functional collaboration and communication in English.

Responsibilities

  • Establish and maintain reporting processes for Quality KPIs across global affiliates.
  • Coordinate inspection readiness activities throughout CSL's global affiliate network.
  • Ensure policies, SOPs and documentation stay current and compliant with regulatory requirements.
  • Integrate Affiliate Quality SOPs with Global CSL procedures and update accordingly.
  • Provide quality support to US Commercial Operations and Product Technical Complaint activities.
  • Support Global Change Control, Deviation, and CAPA processes across regions.
  • Contribute to product release activities for US and export products.
  • Lead or assist in global electronic quality system implementations (SAP, MDG, DocNet).
  • Communicate progress, risks, and compliance matters to internal and external stakeholders.

Skills

Quality systems
GxP-regulated
CAPA
Stakeholder management
Project management
Communication
SAP
Veeva
TrackWise
SharePoint

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Office

Job description

CSL Vifor is seeking a Quality Manager (m/f/x) based in the EU to oversee affiliate quality operations across Europe and global affiliates. The role focuses on inspection readiness, governance of quality systems, and harmonization of processes in a complex international setting.

You will partner with Quality leaders across functions to ensure policies and SOPs are fit for purpose and regulatory compliant, while supporting global quality initiatives and product release activities for the US

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