Senior Manager Quality Management GCP (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 target definition by 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

  • Manage and support continuous improvement of the QM system related to GCP
  • Represent QA in Team meetings
  • Contribute to evaluate and manage protocol deviations and GCP violations
  • Provide QA advice to internal staff and external vendors
  • Plan, prepare, conduct and follow-up GCP audits (investigator sites, vendors, processes, systems, documents)
  • Manage external GCP-QA related service providers and external auditors
  • Lead internal inspection readiness activities with respect to GCP
  • Prepare, conduct and follow-up internal GCP related inspections
  • Prepare, host and manage GCP inspections by health authorities and audits by external partners
  • Conduct QA review of clinical trial specific documents as requested
  • Support the selection and qualification of GCP providers
  • Conduct of internal trainings related to GCP

Your qualifications

  • University degree in biology, biochemistry, chemistry, medicine or related discipline
  • Ideally at least five years professional experience in the area of GCP – preferable some experience in QMS/QA
  • Fluent in written and spoken English
  • Expert knowledge in the area of GCP and in national and international regulations (mainly EU and US)
  • Excellent Team Player and strong, hands-on personality
  • German work permit is mandatory
     

We offer

  • Flexible working time
  • Mobile working
  • 30 days paid vacation
  • Formycon pension
  • Group accident insurance
  • Formycon card
  • Continuing education offers
  • Team spirit, great working atmosphere 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: +49 89 1241 46 204