Quality Auditor & Regulatory Compliance Specialist (m/f/d) - Group Quality Plasma

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.

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 data, trends, and risks
• Prepare regulatory responses for marketing authorizations and PMF approvals
• Collaborate with internal and external stakeholders, including suppliers, health authorities, and cross-functional departments

Your 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 organizational skills
• Fluency in English and German is required
• Willingness to travel internationally (up to 40%)
• Valid driver's license

Your department - where you make an impact

We, the Group Quality department, are responsible for the development of policies and procedures for all GQ Plasma activities based on current applicable regulations to ensure a standardized approach throughout the organization.

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.

Thrive with us

• Company restaurant & meal subsidy
• Training & further education
• Health promotion
• Parking spaces and good public transport connections
• Company and team events

Enjoy these attractive benefits! You can find all offers here: Benefits

The minimum gross salary according to the collective agreement (chemical industry) is EUR 4,270.14 based on 38 hours per week (full-time). As we strive to offer a salary that reflects your individual profile and qualifications, there is a willingness to pay above the minimum salary.

It´s in our blood

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.

Do you have any questions? Then get in touch with your contact person.

Larissa Amling

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Straße 235, 1100 Wien

T: +43 664 789 53 728

Want to find out more about us?

Visit our website Octapharma Career and follow us daily on LinkedIn.

About Octapharma

Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 195 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.

Apply now