Manager Quality Management - Change Control (gn)

  • Medicine, Pharmacy, Laboratory
  • Quality Management, Quality Assurance
  • Fulltime
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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 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

As Manager (gn) Quality Management – Change Control you will be responsible to manage the change control process during approval phase and for the Life Cycle Management of Formycon’s biosimilar medicinal products.
In your new role you will lead the interaction of the triangle between CMOs, license partners and internal stakeholders.
This will include the following responisbilities:
  • Adapt and improve the change system for commercial set up
  • Management and documentation of change requests and related activities as Change Control Coordinator
  • Lead the interaction between CMOs, license partners and internal stakeholders
  • Follow up on change measures and check effectiveness of change implementation
  • Coordinate and prioritize change control requests
  • Create PQR queries and change control metrics (KPIs)
  • Intensive collaboration with other departments, e.g., regulatory affairs, process sciences, drug product, Quality Control and the Qualified Person
  • Support the Qualified Person in the disposition of concerned batches
  • Continuous improvement of the change control process

Your qualifications

  • Completed bachelor’s degree, ideally a higher degree in pharmacy, chemical engineering, biotechnology, or a related field
  • Minimum of 3 years' experience in pharmaceutical QA and compliance functions with focus on change control, ideally in the bio-technological area
  • Sound knowledge of cGMP requirements, EU/FDA regulations and compliance
  • Knowledge of medical device regulations and manufacturing is a plus
  • Very good team player, result oriented, persistent, well organized, proactive, problem solver and able to work independently
  • Fluency in written and spoken English, good command of German

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.