Senior QA & Project Manager (m/w/d)

Fresenius Kabi Austria, with headquarters in Graz and further production site in Linz, is a subsidiary of Fresenius Kabi AG, a world leading manufacturer of infusion therapy and clinical nutrition products. Fresenius Kabi Austria has 1600 employees and ranges among the top enterprises of the region.

• Einsatzort:
  Graz
• Ausmaß:
  Full-time
• Eintrittsdatum:
  asap
• Anstellungsverhältnis:
  unlimited

• Reliable employer
• Strong global growth
• International career opportunities
• Comprehensive education and training
• Homeoffice
• Jobticket
• Active health promotion
• Free parking space
• Bikeleasing
• Canteen
• Joint company events

Fresenius Kabi Austria
Mag. Michaela Illek
Hafnerstraße 36
8055 Graz

Senior QA & Project Manager (m/w/d)

• QA Support and Advice: Provide support and guidance to central teams, local QA, QC, and plant teams to address compliance gaps and enhance local knowledge and skills.
• Hands-On Approach: Collaborate with organizations to prepare documentation, ensuring knowledge transfer and skill development at the plant level.
• Audits and Inspections: Conduct onsite and remote assessments in an audit/inspection style to verify compliance with standards and readiness for authority inspections.
• Participate in global quality system harmonization initiatives.
• Develop and review global SOPs.
• Support supplier audits and ensure global SOPs and processes are implemented.
• Prepare organizations for regulatory audits, conduct pre-audits, and provide support during and after inspections.
• Central Function Activities: Manage tasks such as SOP distribution, eDMS transfers, KPI reviews, audit outcome reporting, quality culture projects, training setups, PQR reviews, and SharePoint updates.
• Lead harmonization and critical business projects.
• Regulatory Monitoring and Improvement: Track GxP/ISO regulatory developments and propose quality improvement initiatives to local and QA management.
• Documentation: Prepare and revise quality management documents in line with GMP, ICH, ISO, and applicable national/international legislation.
• Quality Initiatives: Execute quality improvement projects in close collaboration with Competence Centers.

• Educational skills: MSc in Pharmacy, Chemistry, Biology, Chemical engineering or other relevant education.
• At least 5 years of experience the pharmaceutical GxP environment and proven knowledge on the requirements and application of pharmaceutical quality systems, GMP/cGMP/21 CFR guidelines, WHO GMP and ISO 9001/13485.
• Management skills are important as well as being able to organize and coordinate multiple tasks in several organizations.
• In order to be successful in this position we are looking for a person with good communication skills, confident in English and as well strong integrity.
• Routine travels for on-site support of organizations.

• International challenges in a dynamic corporate environment
• Corporate social events
• Attractive performance-related salary package (annual gross salary starting at € 80.000,-, overpayment depending on occupational skills and experience)

• Reliable employer
• Strong global growth
• International career opportunities
• Comprehensive education and training
• Homeoffice
• Jobticket
• Active health promotion
• Free parking space
• Bikeleasing
• Canteen
• Joint company events