Senior Manager Quality Management- Supply Chain (gn)

  • Work experience
  • Quality Management, Quality Assurance
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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 Senior Manager Quality Management – Supply Chain you will be responsible to review the batch and testing records of the contract manufacturers for every stage of the production process of Formycon’s sterile biotechnology products. In close cooperation with the Qualified Person and Supply Chain you ensure the market supply.

In your new role you will also be responsible for the oversight of the CMOs and coordinate and follow up on product complaints. You lead the compilation of Product Quality Review / Annual Quality Review. This includes but is not limited to the following tasks:
  • Implement internal system for batch record review
  • Review the batch and testing records of the contract manufacturers for every stage of the production process of Formycon’s sterile biotechnology products
  • Support the Qualified Person with the batch disposition and with the coordination of the timely release of the batches according to the supply chain planning
  • Manage the complaint process and respective actions
  • Follow up on batch record observations with your contact persons at the CMOs and evaluate respective CAPA
  • Lead the compilation of the Product Quality Review / Annual Quality Review document based on the supplier information with support by other operational departments
  • Define, collect and perform KPI analysis. Communicate KPIs internally and to the suppliers and request appropriate CAPA and follow up on their implementation
  • Represent quality department in meetings and serve as quality representative
  • Support the supplier oversight for re-validation, changes, deviation, OOS and CAPA

Your qualifications

  • Bachelor’s degree, ideally a higher degree in pharmacy, chemical engineering, biotechnology, or a related field
  • Minimum of 5 years’ experience in pharmaceutical QA and compliance functions with focus on batch release and complaint handling, ideally in the bio-technological area
  • Sound knowledge of cGMP requirements, EU/FDA regulations and compliance
  • Experience in IMP supply chain is an added value
  • Knowledge of medical device regulations and manufacturing is a plus
  • Knowledge of ERP is desirable
  • 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