Head of Quality Management GCP (gn)

  • Medicine, Pharmacy, Laboratory
  • Quality Management, Quality Assurance
  • Fulltime
scheme imagescheme imagescheme image
Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of more than 200 highly skilled 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.
Our focus is on treatments in ophthalmology and immunology as well as for other key chronic diseases. Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines.

To support our Quality Management 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

  • Provide leadership and direction for ongoing projects and in cross-functional teams on GCP related activities and act as GCP expert in the field of clinical studies as well as associated bioanalytical methods
  • Lead inspection readiness activities and support inspection preparation on site at sponsor as well as vendor and site level
  • Host inspections at sponsor by regulatory authorities (local, FDA, EMA)
  • Maintain and continuously improve GCP related processes, systems and associated governing documents (SOPs etc.)
  • Set GCP QA objectives, monitor the progress and report status in management review meetings. Co-operate with internal and external stakeholders to achieve GCP QA objectives
  • Oversee outsourced GCP QA activities (e.g. audits) and contractors
  • Contribute and implement GCP and GCLP compliant risk-based audit strategy and vendor management
  • Lead and mentor members of the GCP QM team

Your qualifications

  • Ideally at least 10 years professional experience in the area of GCP – with strong experience in clinical study management & inspection preparedness activities
  • Strong expert knowledge in the area of ICH GCP and in national and international regulations (mainly EU and US)
  • Experience in GCLP and bioanalytical methods as well as experience at CRO and Sponsor environments would be of advantage
  • University degree in life sciences, medical/pharmaceutical sciences or related discipline
  • Fluent in written and spoken English
  • Excellent team player and strong, hands-on personality
  • Problem-solving skills with ability to analyse situations while considering future impact
  • Independent working style
  • Leadership experience and ability to build and manage a high performing team

We offer

  • Flexible working time
  • Hybrid work
  • 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.

For any questions, please feel free to send us an email at recruiting@formycon.com.