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Louvain-la-Neuve, Belgium

Quality Assurance Manager (M/F)

  • Experience 6 to 10 years 10 years or more
  • Type of role Quality, Security & Environment R&D, Science & Technology
  • Region Brussels
  • Activity Medical devices Pharmaceuticals

Contact Antoine Paternostre
Email
+32 (0)494 83 14 80

More info on Vesale Bioscience

Vesale Bioscience, a Vesale Pharma spin-out, is dedicated to organizing the development, production and distribution of bacteriophages. Modern phage therapy is the most promising treatment against antiobiotic multiresistant bacterial (AMR) infections, one of the biggest global health challenges, referred to as “the next pandemic” by the WHO. AMR is expected to become the single largest death cause within the next quarter century, surpassing cancer.

Vesale Bioscience has developed "Inteliphage", a revolutionary automatic phagogram, IVD for a fast screening of phages. This equipment provides a diagnosis in three hours instead of the usual three days, allowing Vésale to recommend and deliver a personalized and highly effective treatment in record time, which is life-saving in many critical circumstances. In 2021, Vesale Bioscience received the BioFIT award for the most innovative life sciences start-up in Europe.

Vesale Bioscience has a close Research and Development collaboration in phage therapy with The Belgian Defense (Queen Astrid Military Hospital) and other major European Institutions. Find more information on https://phage.health

They are looking for that person who wants to be a valued contributor and member of a talented and dynamic team (M/F): Quality Assurance Manager.


Responsibilities:

As a QA Manager, you create and support a quality culture across the company by driving compliance activities throughout the product life cycle. Reporting to the COO, you drive the QMS implementation, audits, complaints, CAPA, continuous improvement, and GMP/GCP/GDP compliance. The QMS covers the phagogram development (IVD device), and the phage R&D, production and distribution.

Responsibilities:

  • Support design, implementation, maintenance and continuous improvement of the QMS.
  • Ensure QMS consistency and compliance with IVDR, FDA and other regional legislation.
  • Ensure applicable ISO requirements from a quality, safety and efficacy point of view.
  • Acts as Person Responsible for Regulatory Compliance (PRRC) as defined by IVDR requirements.
  • Supervise the QP for GMP/GCP/GDP compliance from a quality, safety and efficacy point of view.
  • Lead quality efforts in corporate development of analytical methods.
  • Ensure lab assets are maintained and inspected in line with standards and legal requirements.
  • Collect and analyze performance data and monthly reporting quality key performance indicators.
  • Supervise the program of site internal auditing. Acting as primary contact for customer audits.
  • Keep abreast of changes in quality regulations, report business impacts to the management team.

Profile:

  • You hold a master’s degree in sciences, or equivalent through experience.
  • Minimum of 4 years of experience in quality assurance in IVD/MD company(ies).
  • Solid knowledge of regulatory requirements, standards and guidance associated to IVD products including but not limited to IVDR ((EU) 2017/746), ISO13485, ISO14971, ISO20916.
  • Knowledge of GMP/GCP/GDP legislation is a plus.
  • You are organized, analytical and autonomous. Leadership and cross-functional team spirit.
  • You work as an entrepreneur with a quality and result mind.
  • You are familiar with IT tools (MS Office, SharePoint, Flowcharting software, Acrobat).
  • Good written and oral communication skills in English.

Offer:

  • A challenging position within a high-potential biotech company.
  • The opportunity to take part in the development of robust modern solutions to fight antibiotic-resistant infections.
  • An attractive compensation package in line with the position’s responsibilities and your experience.

Your application and related information will remain strictly confidential.

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