Quality Manager Qualification (gn)

  • Medicine, Pharmacy, Laboratory
  • Quality Management, Quality Assurance
  • Fulltime
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Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars.
With an experienced team comprised of more than 170 professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.

Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 fusion protein.

To support our team in Martinsried near Munich, we are looking for suitable candidates for this full-time and permanent position, to begin work as soon as possible.

Your responsibilities

System qualification
  • Establishment and continuous improvement of a GxP compliant process for system qualification
  • Ensure compliance with current GxP and data integrity guidelines
  • Main contact person in the quality area for all qualification topics
  • Conduct classroom training and one-on-one training sessions
  • Support and coaching of staff and especially key operators on qualification and data integrity issues
  • Interface between the specialist departments, QM and IT
  • Quality review of qualification documents
  • Oversight of external qualification and maintenance
  • Maintenance of the qualification master plan
  • Oversight of system related changes, deviations, CAPA and risk assessments
Qualification of IT infrastructure
  • Support IT on IT infrastructure qualification issues
  • Review of IT qualification documents, support of internal IT audits as SME
Support as QM member in global projects (e.g. databases)

General quality tasks such as but not limited to:
  • Continuous improvement of the QMS, e.g. by creation of SOP, proactive improvement proposals
  • Development and execution of quality and SOP trainings
Handling internal changes, deviations, CAPA, trend and risk assessments

Your qualifications

  • Bachelor's/Master's degree and 2-5 years of professional experience
  • Good knowledge in the respective functional area
  • Fluent in English and German
Other required expertise, skills and experience:
  •  Strong work moral
  • Strong problem solving skills
  • Good organization skills
  • Attention for details
  • Result orientation
  • Independent working style
  • Good presentation and communication skills
  • Ability to work under pressure

We offer

  • Flexible working time
  • mobile working
  • 30 days paid vacation
  • Formycon pension
  • Group accident insurance
  • Formycon card
  • Continuing education offers
  • Team spirit and great working atmosphere (table football, table tennis, free drinks etc.)
  • and much more!

Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.

Have we sparked your interest? Then we look forward to receiving your application for employment through our online application portal. Please be sure to include all supporting documents, along with your earliest possible starting date and your salary expectations. We look forward to learning about you and the qualifications which you would bring to this position.

Our recruiting process is supported by the recruiter service by Constares GmbH. For initial questions, please contact Rebecca Schön.
  • Frau Rebecca Schön
  • +49 89-1241 46 204