Quality Manager (gn) Laboratories

Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of around 240 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 seeking a highly motivated and detail-oriented Quality Manager for this full-time and permanent position, to begin work as soon as possible.

As a Quality Manager, you will play a crucial role in ensuring compliance with our Quality Management System (QMS) and maintaining high standards of quality across our organization.

The main tasks of this role include the following:

• Conduct quality checks on documents created by various departments
• Review analytical summary documents and reports for accuracy and compliance
• Provide input and review method qualification/validation processes
• Handle internal changes, deviations, Corrective and Preventive Actions (CAPA), trend analysis, and risk assessments
• Support internal training programs and self-inspections
• Write and review Standard Operating Procedures (SOPs) and contribute to the continuous improvement of the QMS
• Serve as a backup for the training process

The general responsibilities of this position are:

• Ensure compliance with QMS requirements
• Take accountability for deadlines within your area of expertise
• Continuously improve internal quality standards and workflows
• Independently plan and prepare department-related documents and activities, coordinating with other departments
• Participate in technical team meetings (both internal and external) as a specialist
• Provide technical guidance to colleagues
• Prepare quality management (QM) documents
• Participate in internal and external audits and inspections
• Establish and coordinate complex interactions and relationships with internal departments

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 .