Life Scientist, Pharmacist - Quality Management Lead (m/f/d)- AiCuris Anti-infective Cures AG

☞ AiCuris Anti-infective Cures AG

Ver: 163

Dia de atualização: 24-10-2024

Localização: Wuppertal North Rhine-Westphalia

Categoria: Ciência Labor

Indústria: Pharmaceuticals

Posição: Director

Tipo de empregos: Full-time

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Conteúdo do emprego

The Powerhouse for Anti-infectives – Committed to making the difference

AiCuris is a pharmaceutical company specializing in the discovery, research and development of novel, resistance‐breaking antiviral and antibacterial agents for the treatment of serious and potentially life-threatening infectious diseases. Founded in 2006 as a spin‐out from Bayer Infection Research, AiCuris today manages an innovative pipeline of anti-infective agents with a team of internationally recognized scientists in Research and Development. We are one of the few European biotech companies that have brought a drug with “blockbuster” potential to the market (Prevymis® 2017/18).

Ready to fight against infectious diseases? Join our team!

Quality Management Lead (m/f/d)

in full time / reporting to the Head of Regulatory Affairs and Compliance

At AiCuris, ensuring quality of our products and processes is of highest importance. Bringing broad knowledge to the quality assurance function, you will work together with our project teams during drug development up to approval regarding all quality aspects related to our development projects covering small molecules and biologics.
  • Improve and maintain the QM system
  • Develop the audit program together with the team
  • Work with consultants, e.g., external auditors related to the development activities
  • Conduct external and internal compliance audits
  • Prepare for inspection by regulatory agencies
  • Provide guidance regarding GxP requirements to the various teams
  • Review and approval of quality agreements
  • Support change control and deviation management
  • Provide information on proposed and current FDA/EMA regulations and guidelines and their impact on AiCuris projects from the QA perspective
  • Bachelor’s degree in Life Science
  • 5-10 years of quality assurance experience in the pharmaceutical industry covering drug development and marketing with focus on GMP
  • Experience in GLP, GCP or GVP is a clear plus
  • Experience in the implementation and maintenance of quality systems in the pharmaceutical industry according to EU and US requirements
  • Experience and knowledge of the related current requirements in the US and Europe
  • Excellent communication, team working and leadership
  • Good organizational and intercultural skills
  • Flexible, scientific working style and willingness for continuous education
  • Fluency in English
  • Cooperation in multinational and interdisciplinary teams
  • An exciting field of activity in a promising research and development company
  • Flexible working hours and self-determined time management
  • Flexible combination of on-site work and mobile working
  • Regular and targeted further training and individual development opportunities
  • Attractive remuneration and company pension scheme
  • A wide range of offers in terms of health care and work-life balance
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Data limite: 08-12-2024

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