Quality Manager

AARDEX Group develops and markets solutions to manage medication adherence in clinical trials. Our customers are pharmaceutical and biotechnological companies which implement adherence solutions to speed up Clinical Drug Development.

For over 35 years, AARDEX is the world market leader in clinical trials (200+ drug trials) and research settings (800+ peer-reviewed publications) with more than 1 million patients monitored across 70+ countries.

This experience results in long-established key client relationships with most major pharmaceutical and biotechnology companies, primarily in the US and in Europe.

The mission of AARDEX Group is to develop and market eco-systems to measure, analyze, and exchange dosing history data to support successful management of patients’ adherence to medications.

The vision: Data driven adherence feedback enabling digital therapeutics and patient empowerment.

Context:

AARDEX’s customers are research-based pharmaceutical or biotechnological companies with a drug pipeline in development phase (II or III).

The AARDEX solutions are used primarily during clinical trials, whereby the measured patient adherence data are used by the Sponsor, CRO’s and sites to ensure fidelity to the research protocol.

To grow its QA department, AARDEX is looking for a fulltime experimented quality manager.

Responsibilities as quality manager

  • Manage and further develop the quality management system
  • Support the operational team in quality records
  • Work with the related regulation frameworks (ISO-9001, ISO-13485, IEC-62304, ISO-27001, GCP, GDPR, HIPAA, 21/CFR11, EU Annex 11, etc.)
  • Manage audits by customers and partners (Pharma, biotech, CRO, CMO)
  • Manage customers interaction regarding satisfaction and product quality
  • Collect, analyze, and report data to management

Role and responsibilities as AARDEX Group employee

  • Be open-minded, proactive and team player
  • Taking part in strategic decisions related to QA and company success
  • Act as AARDEX group ambassador, promoting our values

Profile and competencies

  • Strong skills in Software as a Service environment and IT background
  • Good knowledge of the related regulation frameworks
  • Experience in implementing and maintaining ISO quality systems
  • Experience in the pharmaceutical industry is required
  • Experience with medical HW (not qualified as medical device)
  • Good project management skills
  • Ability to handle priorities, stress and deadlines
  • Interpersonal skills and capacity to interact in a multi-disciplinary team
  • Ability to work under limited supervision
  • Fluent in English and French

To apply for this job email your details to job@aardexgroup.com