Job-ID: 62409
Location: Wien, AUT
Job Level: Professionals
Category: Quality
Employment Type: 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.
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.
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, participate 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 data, trends, and risks
* Prepare regulatory responses for marketing authorisations and PMF approvals
* Collaborate with internal and external stakeholders, including suppliers, health authorities, and cross‑functional departments
Expertise and Ideal Skill Set
* Degree in Life Sciences (e.g., Biology, Chemistry, or Pharmaceutical Sciences)
* Professional experience in Quality Assurance within the pharmaceutical industry
* Proficient knowledge of GMP, EU and FDA guidelines
* Experience with quality management systems, particularly Veeva
* Auditor certification, audit experience, basic quality auditor or ISO course is a strong advantage
* Structured, reliable, and independent working style, combined with strong communication skills
* Ability to manage priorities, meet deadlines, and demonstrate excellent organisational skills
* Fluency in English and German is required
* Willingness to travel internationally (up to 40 %)
* Valid driver’s licence
Department
* We, the Group Quality department, develop policies and procedures for all GQ Plasma activities based on current applicable regulations, ensuring a standardised approach throughout the organisation.
* We are divided into GQ Plasma, GQ Control, GQ Assurance, Group Stability Studies, Group QC Method Validation, Group QC Incoming Goods and Group Quality & Compliance Projects.
Benefits
* Company restaurant & meal subsidy
* Training & further education
* Health promotion
* Parking spaces and good public transport connections
* Company and team events
The minimum gross salary according to the collective agreement (chemical industry) is EUR 4,270.14 based on 38 hours per week (full‑time). Octapharma is willing to pay above this minimum based on individual profile and qualifications.
We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application – regardless of age, gender, origin, sexual orientation, and religion.
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