Our client is a young company who 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.
Our client 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 the company to recommend and deliver a personalized and highly effective treatment in record time, which is life-saving in many critical circumstances
They are looking for that person who wants to be a valued contributor and member of a talented and dynamic team (M/F)
As Quality Assurance Manager, you will be responsible for creating and supporting a quality culture across the company by driving compliance activities through product life cycle.
This includes driving the Quality and Compliance activities for the QMS implementation, audits, complaints, CAPA, continuous improvement, GMP/GCP/GDP compliance.
The QMS will cover not only the phagogram development which is a IVD device (outsourced production), but also the phage R&D, production (lab) and distribution.
- Support design, implementation, maintenance and continuous improvement of the QMS.
- Ensure the QMS is in place and is recognized, understood and maintained across the company.
- Define priorities, build processes and maintain applicable QMS sections to ensure consistency and compliance to IVDR, FDA and other regional legislation (China, Japan,…), as well as supervise GMP/GCP/GDP processes.
- Communicate internally on the QMS implementation and review progress
- Ensure compliance to Medical Devices and In-Vitro Diagnostics regulations, 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 Person Responsible for GMP/GCP/GDP compliance from a quality, safety and efficacy point of view.
- Lead quality efforts in corporate development of analytical methods.
- Work closely with internal and external business partners in driving quality into the IVD pre- and post-market activities
- Ensure lab assets are maintained and inspected in line with standards and legal requirements
- Collect and analyze performance data against defined parameters and monthly reporting quality key performance indicators.
- Supervise the program of site internal auditing. Acting as primary contact for customer audits at site.
- Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implication regarding these changes.
- Report to the COO.