News & Events

  • December 2017 :

    • Senior QA Quality Manager Open Position
    • On the 28th of November, Dominique Demolle will give a talk at the Partnership in Clinical Trials annual event entitled "Characterization of Individual Patient Placebo Response: Positive impacts on clinical trials" during stream 3 Mobile Health.
    • On the same day, Alvaro Pereira has been invited to present Tools4Patient and Placebell technology for patient stratification at Biowin "Tasting around artificial intelligence in healthcare and life sciences" event
  • October 2017 :

    • Dr. Alvaro Pereira, Tools4Patient CSO, will give a presentation entitled " Prediction of patient placebo response has become a reality: impact on clinical development" during Aepodia's 10th anniversary celebration on October 12 at Louvain-la-neuve, Belgiu
  • September 2017 :

    • From the 6th to 8th of September 2017, Tools4Patient will be participating at the European Pain Federation (EFIC) World Meeting in Copenhague, Denmark
  • June 2017 :

    • From the 4th to the 8th June, Tools4patient will be present at the International Congress of Parkinson's disease and movement disorders in Vancouver, Canada
    • On the next 18th to 22nd of June 2017, Tools4Patient will be attending the DIA world meeting in Chicago, USA.

Job Opportunities

Senior QA Quality Manager

You will be responsible for developing and maintaining a level of excellence in all our Tools4patient clinical QA activities. You will report to our CEO and work in partnership with our Tools4patient operational and scientific groups to assist with all the clinical-related activities conducted by Tools4patient on behalf of its sponsors’ clients or for its own R&D activities, globally and at all stages of drug development.

 

You will ensure that T4P activities are carried out in compliance with international requirements for Good Clinical Practice (GCP) and other relevant (inter)national regulations. You will be responsible for managing, conducting and/or participating in regional/global audits. You will use your technical expertise to identify and resolve quality issues.

 

Your responsibilities

 

The T4P Quality Management System

 

You will be responsible for the maintenance and future development of our T4P Quality Management System in line with our business activities (including software development). More specifically you will:

 

  • maintain and develop SOPs for the activities undertaken by T4P. This will include remaining up to date with regulatory developments to ensure T4P meets its strategic quality, business model and effectiveness objectives, and interpreting the requirements of regulatory authorities and advising on their implementation throughout T4P;
  • maintain and improve the T4P Quality Management System by identifying root causes of process and/or system non-conformance, and by dealing with observed gaps in these processes and systems;
  • carry out risk assessments;
  • plan and/or implement appropriate quality controls, quality assurance and audits to ensure our activities are conducted and data are generated, documented and reported in compliance with the protocol, GCP and applicable regulatory requirements; and
  • assist with T4P software validation.

 

You will be responsible for providing unsupervised expert GCP advice to key personnel. This will include, but will not be limited to:

  • developing training materials and providing GCP training, as well as coaching for other employees on QA-related processes.

 

You will be responsible for preparing for regulatory inspections at T4P and/or partner sites across the region and worldwide. In particular, you will:

  • analyze risks, establish an inspection readiness strategy and manage the harmonious roll-out of the inspection readiness program across departments and territories; and

 

  • manage GCP inspections. This will include communicating with the regulatory authorities, preparing for inspections, hosting inspections, assisting with CAPA and monitoring follow-up to ensure any risks/non-conformance identified by inspectors/investigators are addressed appropriately and mitigated.

 

You will be responsible for privacy policy implementation and maintenance, to ensure our T4P activities meet the relevant national, European (GDPR) and regional requirements.

 

You will develop and manage communication between the QA departments of service providers for the purposes of QA oversight and mitigate any risks to T4P business.

 

Necessary prior experience

  • A minimum of 5 to 8 years’ experience at a similar post; and
  • Ability to prioritize business, i.e.  evaluate the importance of issue/gap analysis and impacts on business.

 

We can offer you:

 

  • A chance to work for a dynamic and flourishing company;
  • An innovative and challenging work environment; and
  • A place in a team of enthusiastic and helpful colleagues.