AOP Orphan Pharmaceuticals AG

AOP Orphan is a European pioneer in the development, marketing and distribution of medicines for people with rare and complex diseases. To enhance our team in Vienna Headquarters we are looking for a:

QM Manager/ Product Quality Owner (f/m/d)

Professional Skills

  • Natural science/scientific background (HTL, FH, university)
  • +5 years’ experience in the pharmaceutical industry in the field of
    QM/QA, QC, production and/or CMC
  • Profound GMP knowledge and audit experience desirable
  • Proven experience in managing multiple projects and being able to
    priorities and self-manage
  • Strong communication and presentations skills in English and German
  • IT skills (Office 365, Adobe Acrobat)

As part of our Quality Team you will be responsible for the end to end product quality oversight during development and life cycle.

Ready for an ambitious job?

  • You represent all Quality functions on the Technical Product Team
  • You review key documents from CMOs and prepare/review Product Specifications, Comprehensive Diagrams, Elemental Impurity Assessments and Change Control Documents
  • You trend stability studies and batch release data for the product

Like to take accountability?

  • You actively participate in the continuous improvement of the respective product
  • You are responsible for Incident Management (deviations, OOS) and the ongoing stability program of the respective product

Able to align?

  • You are a team player and like to work cross-functionally and with CMOs
  • You work in close cooperation with different quality functions (for quality agreements, audits,…)
  • You prepare Annual Product Quality Reviews (PQRs) and review and assess PQRs from CMOs

Looking for an agile environment?

  • You enjoy working in a high-performing international environment
  • You prefer a high degree of independence and responsibility for assigned projects
  • You have a pro-active attitude and a creative approach to problem-solving

The gross monthly salary provided for this function is a minimum of € 3.500.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.

Take this AOPPORTUNITY and apply now.

Your contact
Angelika Drabek
+43 1 503 72 44-62