Head of Quality Management- Analytical Laboratories (gn)

  • Formycon AG
  • 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 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 permanent position to begin work as soon as possible.

Your responsibilities

As Head of Quality Management – Analytical Laboratories you will be responsible for ensuring the maintenance and continuous improvement of Formycon's GMP-based Quality Management System (QMS) with respect to our development and GMP QC laboratories.

In your new role you will lead a team of QM managers. You will be acting as a quality expert and consult your internal colleagues of the various operational departments on all matters of quality. Your reporting line is to the Associate Director QM.
  • Management and development of the QM team responsible for analytical lab activities
  • Responsible for all internal quality processes as change control, deviations, training, review of analytical documents, internal audit, equipment qualification and validation of computerized systems
  • Provide expert advice to Formycon’s internal processes within relevant departments (e.g., Protein Analytics, Drug Product and IT) for quality related topics
  • Support continuous improvement of our internal Quality Management System
  • Write / review SOPs
  • Define and generate key performance indicators (KPI) and metrics and keep oversight and control on performance and efficiency of processes
  • Preparation of and lead in regulatory inspections and customer audits and ensure close follow-up of corresponding CAPA plans
  • Training and further education of the laboratory team on quality and data integrity standards including occupational health and safety

Your qualifications

  • Degree (master, diploma, PhD) in pharmacy, chemical engineering, biotechnology, or a related field
  • Minimum of 6 years’ experience in pharmaceutical QA and compliance functions with focus on analytical development and QC activities
  • Proven track record on data integrity requirements, equipment qualification and validation of computerized systems
  • Experience in FDA inspections would be of benefit
  • Very good knowledge of international GxP regulations
  • Excellent staff leadership and communication skills
  • Fluent in written and spoken English, good command of German
  • Very good team player, result oriented, persistent, well organized, proactive, problem solver and able to work independently

We offer

  • Flexible working time
  • 30 days paid vacation
  • Formycon pension
  • Group accident insurance
  • Formycon card
  • Continuing education offers
  • Team spirit and great working atmosphere (table football, table tennis, free drinks etc.)
  • 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.
  • Rebecca Schön
  • +49 89-1241 46 204