Stellen-ID: 62409
Standort: Wien, AT
Karrierestufe: Professionals
Fachbereich: Quality
Beschäftigungstyp: Permanent position
Become part of a vital chain and contribute to our common goal of making people’s lives better. Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organisation.
As a Quality Auditor & Regulatory Compliance Specialist, you are responsible for ensuring the quality and regulatory compliance of Octapharma’s plasma suppliers on a corporate level.
The role combines supplier qualification, audit activities, and regulatory tasks, with a strong focus on data accuracy, compliance, and structured stakeholder interaction.
With over 1700 employees, the Octapharma site in Vienna is the largest production site, and successful research and development location.
Your main tasks and responsibilities
Ensure quality and regulatory compliance of plasma suppliers on a global level
Manage change control, deviations, and quality-related contracts
Conduct external supplier audits, participation in customer/internal audits at our facility
Analyze and trend supplier-related quality data
Create, review, and train on SOPs and related procedures
Qualify plasma suppliers and service providers (e.g. testing laboratories, logistics partners)
Monitor and ensure continuous supplier compliance throughout the lifecycle of supply agreements
Maintain and annually update plasma supplier data
Perform data entry, second-level checks in a Regulatory Database
Ensure compliance with EU and EMA Plasma Master File (PMF) requirements
Prepare regulatory documentation for annual PMF submission; evaluate epidemiological dat